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Prof. Dimitar Shishkov, MD - Form 483, 2024-12-12

$289 - Available for instant download

Issued On: December, 2024

Inspection Type: FDA 483

Site Name: Dimitar Shishkov, MD [Plovdiv / Bulgaria]

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Roger S. Keresztes, M.D. - Form 483, 2024-12-12

$289 - Available for instant download

Issued On: December, 2024

Inspection Type: FDA 483

Site Name: Roger S. Keresztes, M.D. [Stony Brook / United States of America]

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K.B. Specialty Foods - Form 483, 2024-12-12

$289 - Available for instant download

Issued On: December, 2024

Inspection Type: FDA 483

Site Name: K.B. Specialty Foods [Greensburg / United States of America]

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KENIL HEALTHCARE PRIVATE LIMITED - Form 483, 2024-12-11

$289 - Available for instant download

Issued On: December, 2024

Inspection Type: FDA 483

Site Name: KENIL HEALTHCARE PRIVATE LIMITED [Mehsana / India]

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Evonik Corporation - Form 483, 2024-12-10

$289 - Available for instant download

Issued On: December, 2024

Inspection Type: FDA 483

Site Name: Evonik Corporation [Birmingham / United States of America]

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Ikonisys Inc. - Form 483, 2024-12-10

$289 - Available for instant download

Issued On: December, 2024

Inspection Type: FDA 483

Site Name: Ikonisys Inc. [New Haven / United States of America]

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Vee Pak, LLC dba Voyant Beauty - Form 483, 2024-12-10

$289 - Available for instant download

Issued On: December, 2024

Inspection Type: FDA 483

Site Name: Vee Pak, LLC dba Voyant Beauty [Hodgkins / United States of America]

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Ken Y. Yoneda, M.D. - Form 483, 2024-12-06

$289 - Available for instant download

Issued On: December, 2024

Inspection Type: FDA 483

Site Name: Ken Y. Yoneda, M.D. [Sacramento / United States of America]

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Vivant Skin Care, LLC - Form 483, 2024-12-05

$289 - Available for instant download

Issued On: December, 2024

Inspection Type: FDA 483

Site Name: Vivant Skin Care, LLC [Miami Lakes / United States of America]

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J. D. Heiskell Holdings, LLC - Form 483, 2024-12-05

$289 - Available for instant download

Issued On: December, 2024

Inspection Type: FDA 483

Site Name: J. D. Heiskell Holdings, LLC [Twin Falls / United States of America]

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Advocate Lutheran General Hospital Blood Bank - Form 483, 2024-12-05

$289 - Available for instant download

Issued On: December, 2024

Inspection Type: FDA 483

Site Name: Advocate Lutheran General Hospital Transfusion Services [Park Ridge / United States of America]

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Okami Medical Inc. - Form 483, 2024-12-04

$289 - Available for instant download

Issued On: December, 2024

Inspection Type: FDA 483

Site Name: Okami Medical Inc. [Aliso Viejo / United States of America]

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Calumet Karns City Refining LLC - Form 483, 2024-12-04

$289 - Available for instant download

Issued On: December, 2024

Inspection Type: FDA 483

Site Name: Calumet Karns City Refining LLC [Karns City / United States of America]

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Kovas Co., Ltd. - Form 483, 2024-11-29

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: Kovas Co., Ltd. [Sinchon-Dong / Korea (Republic of)]

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Merck Teknika LLC - Form 483, 2024-11-27

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: Merck Teknika LLC [Durham / United States of America]

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RAKSHIT DRUGS PRIVATE LIMITED - Form 483, 2024-11-22

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: RAKSHIT DRUGS PRIVATE LIMITED [Visakhapatnam / India]

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Stridelink Inc - Form 483, 2024-11-20

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: STRIDELINK INC. [Atlanta / United States of America]

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Nutek Orthopaedics, Inc. - Form 483, 2024-11-19

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: Nutek Orthopaedics, Inc. [Fort Lauderdale / United States of America]

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Morristown Medical Center Blood Bank - Form 483, 2024-11-19

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: Morristown Medical Center Atlantic Health Blood Bank [Morristown / United States of America]

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Stryker Medical Division of Stryker Corporation - Form 483, 2024-11-15

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: Stryker Medical Division of Stryker Corporation [Portage / United States of America]

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NYUMBANI HAKUNA MATATA LLC - Form 483, 2024-11-13

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: NYUMBANI HAKUNA MATATA LLC [Buffalo / United States of America]

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Takeda Manufacturing Italia SPA - Form 483, 2024-11-12

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: Takeda Manufacturing Italia SPA [Cittaducale / Italy]

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Takeda Austria GmbH - Form 483, 2024-11-12

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: Takeda Austria GmbH [Linz / Austria]

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FUJIFILM Diosynth Biotechnologies Denmark ApS - Form 483, 2024-11-12

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: FUJIFILM Diosynth Biotechnologies Denmark ApS [Hillerød / Denmark]

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Mark Dacey, M.D. - Form 483, 2024-11-08

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: Mark Dacey, M.D. [Denver / United States of America]

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Nang Kuang Pharmaceutical Co. Ltd. - Form 483, 2024-11-07

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: Nang Kuang Pharmaceutical Co. Ltd. [Yong Kang Qu / Taiwan]

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Commercial Plastics Kenosha LLC - Form 483, 2024-11-07

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: Commercial Plastics LLC [Kenosha / United States of America]

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JACKS MFG INC - Form 483, 2024-11-06

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: JACKS MFG INC [Washington Court House / United States of America]

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Evonik Active Oxygens, LLC - Form 483, 2024-11-06

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: Evonik Active Oxygens, LLC [Pasadena / United States of America]

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Kite Pharma, Inc. - Form 483, 2024-11-01

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: Kite Pharma, Inc. [Frederick / United States of America]

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Blendpack, Inc. - Form 483, 2024-11-01

$289 - Available for instant download

Issued On: November, 2024

Inspection Type: FDA 483

Site Name: Blendpack, Inc. [Cleveland / United States of America]

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Advanced Back Technologies, Inc. - Form 483, 2024-10-31

$289 - Available for instant download

Issued On: October, 2024

Inspection Type: FDA 483

Site Name: Advanced Back Technologies, Inc. [Syosset / United States of America]

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Uckele Health & Nutrition, Inc. - Form 483, 2024-10-31

$289 - Available for instant download

Issued On: October, 2024

Inspection Type: FDA 483

Site Name: Uckele Health & Nutrition, Inc. [Blissfield / United States of America]

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Houchin Community Blood Bank - Form 483, 2024-10-30

$289 - Available for instant download

Issued On: October, 2024

Inspection Type: FDA 483

Site Name: Houchin Community Blood bank [Bakersfield / United States of America]

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Robert Chrzanowski, M.D. - Form 483, 2024-10-29

$289 - Available for instant download

Issued On: October, 2024

Inspection Type: FDA 483

Site Name: Robert Chrzanowski, M.D. [Columbus / United States of America]

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PureTek Corporation - Form 483, 2024-10-24

$289 - Available for instant download

Issued On: October, 2024

Inspection Type: FDA 483

Site Name: PureTek Corporation [Panorama City / United States of America]

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John M. Kirkwood, MD - Form 483, 2024-10-21

$289 - Available for instant download

Issued On: October, 2024

Inspection Type: FDA 483

Site Name: John M. Kirkwood, MD [Pittsburgh / United States of America]

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Jack & The Green Sprouts, Inc. - Form 483, 2024-10-21

$289 - Available for instant download

Issued On: October, 2024

Inspection Type: FDA 483

Site Name: Jack & The Green Sprouts, Inc. [River Falls / United States of America]

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Future Pak LLC - Form 483, 2024-10-15

$289 - Available for instant download

Issued On: October, 2024

Inspection Type: FDA 483

Site Name: Future Pak LLC [Wixom / United States of America]

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Future Pak LLC - Form 483, 2024-10-15

$289 - Available for instant download

Issued On: October, 2024

Inspection Type: FDA 483

Site Name: Future Pak LLC [Wixom / United States of America]

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Arshad M. Khanani, MD - Form 483, 2024-10-11

$289 - Available for instant download

Issued On: October, 2024

Inspection Type: FDA 483

Site Name: Arshad M. Khanani, MD, MA, FASRS [Reno / United States of America]

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Neil S. Sadick, M.D. - Form 483, 2024-10-09

$289 - Available for instant download

Issued On: October, 2024

Inspection Type: FDA 483

Site Name: Sadick, Neil M.D. [New York / United States of America]

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Mannkind Corporation - Form 483, 2024-10-03

$289 - Available for instant download

Issued On: October, 2024

Inspection Type: FDA 483

Site Name: Valeritas, Incorporated [Marlborough / United States of America]

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South Dakota Partners Inc - Form 483, 2024-09-30

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: South Dakota Partners Inc [Clear Lake / United States of America]

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Rocky Mountain Lions Eye Bank - Form 483, 2024-09-27

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: Rocky Mountain Lions Eye Bank [Aurora / United States of America]

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Rocky Mountain Lions Eye Bank - EIR, 2024-10-27

$1190 - Available for instant download

Issued On: September, 2024

Inspection Type: EIR

Site Name: Rocky Mountain Lions Eye Bank [Aurora / United States of America]

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Lincotek Medical LLC. - Form 483, 2024-09-26

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: Lincotek Medical LLC. [Vandalia / United States of America]

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GlaxoSmithKline LLC - Form 483, 2024-09-25

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: GlaxoSmithKline LLC [Conshohocken / United States of America]

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Arkema Inc. - Form 483, 2024-09-24

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: Arkema Inc. [Piffard / United States of America]

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Jeffrey M. Kaplan, M.D. - Form 483, 2024-09-20

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: Jeffrey M. Kaplan, M.D. [Overland Park / United States of America]

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Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) - Form 483, 2024-09-20

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) [Ravensburg / Germany]

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Staska Pharmaceuticals, Inc. - Form 483, 2024-09-26

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: Staska Pharmaceuticals, Inc. [Bennet / United States of America]

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The New York Fertility Center - Form 483, 2024-09-18

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: The New York Fertility Center [Flushing / United States of America]

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Nest Cryobank LLC - Form 483, 2024-09-17

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: Nest Cryobank LLC [San Francisco / United States of America]

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Perrigo New York, Inc. - Form 483, 2024-09-17

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: Perrigo New York, Inc. [Bronx / United States of America]

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Rockwell Medical, Inc. - Form 483, 2024-09-16

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: Rockwell Medical [Grapevine / United States of America]

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WalkMed Technologies, LLC - Form 483, 2024-09-13

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: WalkMed, LLC [Aurora / United States of America]

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COSMECCA KOREA CO., LTD - Form 483, 2024-09-13

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: COSMECCA KOREA CO., LTD [Daeso-Myeon / Korea (Republic of)]

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Kimberly L. Wagner, M.D. - Form 483, 2024-09-13

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: Kimberly L. Wagner, M.D. [Colorado Springs / United States of America]

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Rite-Kem Incorporated - Form 483, 2024-09-12

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: Rite-Kem Incorporated [Tupelo / United States of America]

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Karl Storz Endoscopy - Form 483, 2024-09-12

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: Karl Storz Endoscopy [El Segundo / United States of America]

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Randy D. Hicks, M.D. - Form 483, 2024-09-12

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: Randy D. Hicks, M.D. [Flint / United States of America]

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Sperm Bank, Inc. dba Fertility Center of California - Form 483, 2024-09-11

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: Sperm Bank, Inc. dba Fertility Center of California [Tustin / United States of America]

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Kaiser Foundation Research Institute IRB #8 - Form 483, 2024-09-10

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: Kaiser Foundation Research Institute IRB #8 [Oakland / United States of America]

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Mark Cuban Cost Plus Manufacturing and Compounding LLC - Form 483, 2024-09-06

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: Mark Cuban Cost Plus Manufacturing and Compounding LLC [Dallas / United States of America]

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Alkaline Corporation - Form 483, 2024-09-06

$289 - Available for instant download

Issued On: September, 2024

Inspection Type: FDA 483

Site Name: Alkaline Corporation [Eatontown / United States of America]

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Novo Nordisk Pharmaceutical Industries, LP - Form 483, 2024-08-29

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483

Site Name: Novo Nordisk Pharmaceutical Industries, LP [Durham / United States of America]

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Novo Nordisk Pharmaceutical Industries, LP - Form 483R, 2024-09-29

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483 Response

Site Name: Novo Nordisk Pharmaceutical Industries, LP [Durham / United States of America]

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Novo Nordisk Pharmaceutical Industries, LP - EIR, 2025-02-11

$1190 - Available for instant download

Issued On: August, 2024

Inspection Type: EIR

Site Name: Novo Nordisk Pharmaceutical Industries, LP [Durham / United States of America]

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KC Pharmaceuticals, Inc. - Form 483, 2024-08-28

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483

Site Name: KC Pharmaceuticals, Inc. [Pomona / United States of America]

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Marwan M. Shaykh, M.D. dba Assisted Fertility Program - Form 483, 2024-08-28

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483

Site Name: Marwan M. Shaykh, M.D. dba Assisted Fertility Program [Jacksonville / United States of America]

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Alexander Khoruts, M.D., Sponsor-Investigator - Form 483, 2024-08-26

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483

Site Name: Alexander Khoruts, M.D., Sponsor-Investigator [Minneapolis / United States of America]

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Kelyniam Global, Inc. - Form 483, 2024-08-23

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483

Site Name: Kelyniam Global, Inc. [Collinsville / United States of America]

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Merck Sharp & Dohme LLC - Form 483, 2024-08-23

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483

Site Name: Merck Sharp & Dohme LLC [Lansdale / United States of America]

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Strata Skin Sciences, Inc. - Form 483, 2024-08-22

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483

Site Name: Strata Skin Sciences, Inc. [Carlsbad / United States of America]

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Knox Medical Diagnostics, Inc. - Form 483, 2024-08-21

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483

Site Name: Knox Medical Diagnostics, Inc. [San Francisco / United States of America]

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Sanober Kable, M.D. - Form 483, 2024-08-21

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483

Site Name: Sanober Kable, M.D. [Denison / United States of America]

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Trackx Technology Inc - Form 483, 2024-08-14

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483

Site Name: TRACKX TECHNOLOGY Inc. [Hillsborough / United States of America]

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OAKWOOD LABORATORIES, L.L.C. - Form 483, 2024-08-13

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483

Site Name: OAKWOOD LABORATORIES, L.L.C. [Solon / United States of America]

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NanoString, A Bruker Company - Form 483, 2024-08-09

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483

Site Name: Nanostring Technologies [Seattle / United States of America]

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KYAW KHIN, INC - Form 483, 2024-08-09

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483

Site Name: KYAWKHIN INC [Fort Wayne / United States of America]

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CTK Biotech, Inc. - Form 483, 2024-08-08

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483

Site Name: CTK Biotech, Inc. [Poway / United States of America]

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Intervet Inc. (d/b/a Merck Animal Health) - Form 483, 2024-08-06

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483

Site Name: Intervet, Inc [Madison / United States of America]

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Lucky K.T. Co., Inc. - Form 483, 2024-08-05

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483

Site Name: Lucky K.T. Co., Inc. [El Monte / United States of America]

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Strukmyer Medical - Form 483, 2024-08-01

$289 - Available for instant download

Issued On: August, 2024

Inspection Type: FDA 483

Site Name: Strukmyer Medical [Mesquite / United States of America]

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Brunkow Cheese of Wisconsin, Inc. - Form 483, 2024-07-29

$289 - Available for instant download

Issued On: July, 2024

Inspection Type: FDA 483

Site Name: Brunkow Cheese of Wisconsin, Inc. [Darlington / United States of America]

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Red Oak Instruments, LLC - Form 483, 2024-07-26

$289 - Available for instant download

Issued On: July, 2024

Inspection Type: FDA 483

Site Name: Red Oak Instruments, LLC [Katy / United States of America]

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The Skin Atelier, Inc. dba Skinprint - Form 483, 2024-07-26

$289 - Available for instant download

Issued On: July, 2024

Inspection Type: FDA 483

Site Name: The Skin Atelier, Inc. [Goshen / United States of America]

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Boka Imports LLC - Form 483, 2024-07-25

$289 - Available for instant download

Issued On: July, 2024

Inspection Type: FDA 483

Site Name: Boka Imports LLC [Mission / United States of America]

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Stryker Ireland, Ltd., Instruments Division - Form 483, 2024-07-25

$289 - Available for instant download

Issued On: July, 2024

Inspection Type: FDA 483

Site Name: Stryker Ireland, Ltd., Instruments Division [Cork / Ireland]

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Spok, Inc. - Form 483, 2024-07-19

$289 - Available for instant download

Issued On: July, 2024

Inspection Type: FDA 483

Site Name: Spok Inc. [Hopkins / United States of America]

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Seock-Ah Im, MD, PhD - Form 483, 2024-07-12

$289 - Available for instant download

Issued On: July, 2024

Inspection Type: FDA 483

Site Name: Seock-Ah Im, MD, PhD [Seoul / Korea (Republic of)]

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Chesapeake Medical Products, Inc. - Form 483, 2024-07-12

$289 - Available for instant download

Issued On: July, 2024

Inspection Type: FDA 483

Site Name: CHESAPEAKE MEDICAL PRODUCTS, INC [Rosedale / United States of America]

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Chromak Research, Inc. - Form 483, 2024-07-11

$289 - Available for instant download

Issued On: July, 2024

Inspection Type: FDA 483

Site Name: Chromak Research, Inc. [Avalon / United States of America]

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Knight's Farm Fresh Feeds, Inc. - Form 483, 2024-07-10

$289 - Available for instant download

Issued On: July, 2024

Inspection Type: FDA 483

Site Name: Knight's Farm Fresh Feeds, Inc. [Bushnell / United States of America]

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Ameritek USA, Inc. - Form 483, 2024-07-10

$289 - Available for instant download

Issued On: July, 2024

Inspection Type: FDA 483

Site Name: Ameritek USA, Inc. [Everett / United States of America]

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Welch, Holme & Clark Co.,Inc. - Form 483, 2024-07-10

$289 - Available for instant download

Issued On: July, 2024

Inspection Type: FDA 483

Site Name: Welch, Holme & Clark Co.,Inc. [Newark / United States of America]

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SEKO MedTec Solutions - Form 483, 2024-07-08

$289 - Available for instant download

Issued On: July, 2024

Inspection Type: FDA 483

Site Name: SEKO MedTec Solutions [Oakdale / United States of America]

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Ochsner Health System Blood Bank - Form 483, 2024-07-05

$289 - Available for instant download

Issued On: July, 2024

Inspection Type: FDA 483

Site Name: Ochsner Health System Blood Bank [New Orleans / United States of America]

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