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Jan Matousek, D.O. - Form 483, 2023-11-16
$289 - Available for instant download
Issued On: November, 2023
Inspection Type: FDA 483
Site Name: Jan Matousek, D.O. [West Bend / United States of America]
Eye Bank For Sight Restoration Inc. - Form 483, 2023-11-13
$289 - Available for instant download
Issued On: November, 2023
Inspection Type: FDA 483
Site Name: Eye Bank For Sight Restoration Inc. [New York / United States of America]
Novo Nordisk A/S - 25a-B - Form 483, 2023-11-07
$289 - Available for instant download
Issued On: November, 2023
Inspection Type: FDA 483
Takeda Pharmaceutical Company Limited - Form 483, 2023-11-06
$289 - Available for instant download
Issued On: November, 2023
Inspection Type: FDA 483
Site Name: Takeda Pharmaceutical Company Limited [Mitsui / Japan]
Empack Spraytech Inc. - Form 483, 2023-11-03
$289 - Available for instant download
Issued On: November, 2023
Inspection Type: FDA 483
Site Name: Empack Spraytech Inc. [Brampton / Canada]
Hikma Pharmaceuticals USA Inc. - Form 483, 2023-11-22
$289 - Available for instant download
Issued On: November, 2023
Inspection Type: FDA 483
Site Name: Hikma Pharmaceuticals USA Inc. [Cherry Hill / United States of America]
AGC WAKASA CHEMICALS CO.,LTD. - Form 483, 2023-11-02
$289 - Available for instant download
Issued On: November, 2023
Inspection Type: FDA 483
Biomet UK Ltd. - Form 483, 2023-11-02
$289 - Available for instant download
Issued On: November, 2023
Inspection Type: FDA 483
Site Name: Biomet UK Ltd. [Bridgend / United Kingdom of Great Britain and Northern Ireland]
Curia New York, Inc. - Form 483, 2023-11-01
$289 - Available for instant download
Issued On: November, 2023
Inspection Type: FDA 483
Site Name: Curia New York, Inc. [Rensselaer / United States of America]
Clark, Wayne M. - Form 483, 2023-10-27
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Clark, Wayne M. [Portland / United States of America]
SUMITOMO OSAKA CEMENT CO., LTD. - Form 483, 2023-10-27
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: SUMITOMO OSAKA CEMENT CO., LTD. [Nishikinakacho / Japan]
New York Blood Center Enterprises - Form 483, 2023-10-27
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: New York Blood Center Enterprises [Westbury / United States of America]
Mary Kay Inc. - Form 483, 2023-10-27
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Mary Kay Inc. [Lewisville / United States of America]
Sky Chefs, Inc. (dba LSG Sky Chefs) - Form 483, 2023-10-27
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Sky Chefs, Inc. (dba LSG Sky Chefs) [Ontario / United States of America]
Stokes Healthcare Inc. dba Epicur Pharma - Form 483, 2023-10-25
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Stokes Healthcare Inc. dba Epicur Pharma [Mount Laurel / United States of America]
Dechoker, LLC - Form 483, 2023-10-24
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Dechoker, LLC [Wheat Ridge / United States of America]
KILITCH HEALTHCARE INDIA LIMITED - Form 483, 2023-10-20
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: KILITCH HEALTHCARE INDIA LIMITED [Navi Mumbai / India]
Toshiki Pigment Company Limited - Form 483, 2023-10-20
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Toshiki Pigment Company Limited [Shimookamotocho / Japan]
Diwakar Davar, M.D. - Form 483, 2023-10-19
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Diwakar Davar, M.D. [Pittsburgh / United States of America]
Alkermes, Inc - Form 483, 2023-10-19
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Alkermes, Inc [Wilmington / United States of America]
Links Medical Products Inc - Form 483, 2023-10-18
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Links Medical Products Inc [Laguna Hills / United States of America]
Expackusa, Inc. - Form 483, 2023-10-18
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Expackusa, Inc. [Fair Lawn / United States of America]
Alk-abello, Inc. - Form 483, 2023-10-17
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Alk-abello, Inc. [Port Washington / United States of America]
Newark Beth Israel Medical Center - Blood Bank - Form 483, 2023-10-13
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Newark Beth Israel Medical Center - Blood Bank [Newark / United States of America]
Kaneka Corporation Takasago Plant - Form 483, 2023-10-13
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Kaneka Corporation Takasago Plant [Miyamaecho / Japan]
Fresenius Kabi USA, LLC - Form 483, 2023-10-13
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Fresenius Kabi USA, LLC [Grand Island / United States of America]
Post Oak Innovations, Inc. - Form 483, 2023-10-13
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Post Oak Innovations, Inc. [Dallas / United States of America]
DSP Skin Care LLC - Form 483, 2023-10-12
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: DSP Skin Care LLC [Los Angeles / United States of America]
Kwabena Ntoso M.D - Form 483, 2023-10-11
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Kwabena Ntoso M.D [Philadelphia / United States of America]
Fresenius Kabi Oncology Limited - Form 483, 2023-10-10
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Fresenius Kabi Oncology Limited [Nalagarh / India]
Sinikka L. Green, M.D. - EIR, 2023-11-03
$1190 - Available for instant download
Issued On: October, 2023
Inspection Type: EIR
Site Name: Sinikka L. Green, M.D. [Georgetown / United States of America]
Pepperidge Farm South Bend, IN Bakery Depot - Form 483, 2023-09-29
$289 - Available for instant download
Issued On: September, 2023
Inspection Type: FDA 483
Site Name: Pepperidge Farm South Bend, IN Bakery Depot [South Bend / United States of America]
Sperm Bank, Inc. dba Fertility Center of California - Form 483, 2023-09-29
$289 - Available for instant download
Issued On: September, 2023
Inspection Type: FDA 483
Site Name: Sperm Bank, Inc. dba Fertility Center of California [Tustin / United States of America]
Naked Int'l Inc - Form 483, 2023-09-26
$289 - Available for instant download
Issued On: September, 2023
Inspection Type: FDA 483
Site Name: Naked Int'l Inc [Miami Beach / United States of America]
Berkeley Biologics LLC - Form 483, 2023-09-25
$289 - Available for instant download
Issued On: September, 2023
Inspection Type: FDA 483
Site Name: Berkeley Biologics LLC [Richmond / United States of America]
Dr. Bruce G. Rankin, DO - Form 483, 2023-09-22
$289 - Available for instant download
Issued On: September, 2023
Inspection Type: FDA 483
Site Name: Dr. Bruce G. Rankin, DO [Deland / United States of America]
Quicksilver Scientific - Form 483, 2023-09-21
$289 - Available for instant download
Issued On: September, 2023
Inspection Type: FDA 483
Site Name: Quicksilver Scientific [Louisville / United States of America]
Kentucky Blood Center Inc - Form 483, 2023-09-18
$289 - Available for instant download
Issued On: September, 2023
Inspection Type: FDA 483
Site Name: Kentucky Blood Center Inc [Lexington / United States of America]
Vinay Sikand, M.D. - Form 483, 2023-09-21
$289 - Available for instant download
Issued On: September, 2023
Inspection Type: FDA 483
Site Name: Vinay Sikand, M.D. [Toms River / United States of America]
Fresenius Kabi USA, LLC - Form 483, 2023-09-07
$289 - Available for instant download
Issued On: September, 2023
Inspection Type: FDA 483
Site Name: Fresenius Kabi USA, LLC [North Andover / United States of America]
The Sperm and Embryo Bank of New Jersey, Inc. - Form 483, 2023-09-05
$289 - Available for instant download
Issued On: September, 2023
Inspection Type: FDA 483
Site Name: The Sperm and Embryo Bank of New Jersey, Inc. [Mountainside / United States of America]
Oishi Koseido Co., Ltd. - Form 483, 2023-09-01
$289 - Available for instant download
Issued On: September, 2023
Inspection Type: FDA 483
Sri Krishna Pharmaceuticals Limited - Form 483, 2023-09-01
$289 - Available for instant download
Issued On: September, 2023
Inspection Type: FDA 483
Site Name: Sri Krishna Pharmaceuticals Limited [Hyderabad / India]
Fresenius Kabi USA, LLC - Form 483, 2023-08-30
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Fresenius Kabi USA, LLC [Grand Island / United States of America]
Fresenius Kabi USA, LLC - Form 483R, 2023-08-30
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483 Response
Site Name: Fresenius Kabi USA, LLC [Grand Island / United States of America]
SMITHWORKS, INC. - Form 483, 2023-08-29
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: SMITHWORKS, INC. [Lindale / United States of America]
Virak Orthopedics LLC - Form 483, 2023-08-25
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Virak Orthopedics LLC [Harrison / United States of America]
Berkshire Sterile Manufacturing, Inc. - Form 483, 2023-08-25
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Berkshire Sterile Manufacturing, Inc. [Lee / United States of America]
Fresenius Kabi USA, LLC - Form 483, 2023-08-24
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Fresenius Kabi USA, LLC [Melrose Park / United States of America]
Fairfax Cryobank, Inc. - Form 483, 2023-08-24
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Fairfax Cryobank, Inc. [Fairfax / United States of America]
Dept. of the Army - Armed Services Blood Bank Ctr. - Europe - Form 483, 2023-08-23
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Dept. of the Army - Armed Services Blood Bank Ctr. - Europe [Landstuhl / Germany]
Falck Medical Incorporated - Form 483, 2023-08-21
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Falck Medical Incorporated [Mystic / United States of America]
CieloWorks, Inc - Form 483, 2023-08-18
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: CieloWorks, Inc [Austin / United States of America]
Synlait Milk Limited - EIR, 2023-10-10
$1190 - Available for instant download
Issued On: August, 2023
Inspection Type: EIR
Site Name: Synlait Milk Limited [Pokeno / New Zealand]
Pure Simple Products aka Northern Elderberry - Form 483, 2023-08-16
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Pure Simple Products aka Northern Elderberry [Traverse City / United States of America]
Mak-System Corp. - Form 483, 2023-08-11
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Mak-System Corp. [Des Plaines / United States of America]
Synlait Milk Limited - EIR, 2023-11-14
$1190 - Available for instant download
Issued On: August, 2023
Inspection Type: EIR
Anika Therapeutics Inc - Form 483, 2023-08-09
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Anika Therapeutics Inc [Bedford / United States of America]
Veterans Administration Hospital Blood Bank - Form 483, 2023-08-09
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Veterans Administration Hospital Blood Bank [Fort Harrison / United States of America]
Lewis, Karl D. MD - Form 483, 2023-09-12
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Lewis, Karl D. MD [Aurora / United States of America]
Akeso Biopharma Co., Ltd. - Form 483, 2023-08-07
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Asept Pak Inc. - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Asept Pak Inc. [Malone / United States of America]
Mark A. Stein, Ph.D. - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Mark A. Stein, Ph.D. [Seattle / United States of America]
Steven Sarkisian, M.D - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Steven Sarkisian, M.D [Oklahoma City / United States of America]
Ackermann Usa Inc - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Ackermann Usa Inc [Bayport / United States of America]
MARKSANS PHARMA LIMITED - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: MARKSANS PHARMA LIMITED [Mormugao / India]
Lions Eye Bank For Long Island - Form 483, 2023-08-03
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Lions Eye Bank For Long Island [Valley Stream / United States of America]
Inopak Ltd - Form 483, 2023-08-03
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
King Bio Inc - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: King Bio Inc [Asheville / United States of America]
Williams & Son Livestock, LLC. - Form 483, 2023-07-27
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Williams & Son Livestock, LLC. [London / United States of America]
Novo Nordisk US Bio Production Inc. - Form 483, 2023-07-25
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Novo Nordisk US Bio Production Inc. [West Lebanon / United States of America]
Kofinas Fertility Group - Form 483, 2023-07-25
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Kofinas Fertility Group [New York / United States of America]
KOLMAR KOREA CO., LTD Gwanjeong 2 branch - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: KOLMAR KOREA CO., LTD Gwanjeong 2 branch [Sejong / Korea (Republic of)]
Keystone Industries - Form 483, 2023-07-20
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Keystone Industries [Swedesboro / United States of America]
AKI, Inc. dba Arcade Beauty - Form 483, 2023-07-20
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: AKI, Inc. dba Arcade Beauty [Chattanooga / United States of America]
Glaukos Corporation - EIR, 2023-08-01
$1190 - Available for instant download
Issued On: July, 2023
Inspection Type: EIR
Site Name: Glaukos Corporation [San Clemente / United States of America]
Product Packaging West, Inc. - Form 483, 2023-07-18
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Product Packaging West, Inc. [North Hollywood / United States of America]
Moo Mountain Milk Inc - Form 483, 2023-07-13
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Moo Mountain Milk Inc [Burley / United States of America]
Novo Nordisk Pharmaceutical Industries, LP - Form 483, 2023-07-13
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Novo Nordisk Pharmaceutical Industries, LP [Clayton / United States of America]
Novo Nordisk Pharmaceutical Industries, LP - EIR, 2023-08-29
$1190 - Available for instant download
Issued On: July, 2023
Inspection Type: EIR
Site Name: Novo Nordisk Pharmaceutical Industries, LP [Clayton / United States of America]
Medline Industries, LP (f/k/a Medline Industries, Inc.) - Form 483, 2023-07-12
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Medline Industries, LP (f/k/a Medline Industries, Inc.) [Mundelein / United States of America]
J.M. Smucker LLC - Form 483, 2023-07-10
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: J.M. Smucker LLC [Lexington / United States of America]
K.S.PEARL CO., LTD. - Form 483, 2023-07-07
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: K.S.PEARL CO., LTD. [Incheon / Korea (Republic of)]
Kaysersberg Pharmaceuticals - Form 483, 2023-07-07
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Kaysersberg Pharmaceuticals [Kaysersberg Vignoble / France]
New York Blood Center Enterprises - Form 483, 2023-07-06
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: New York Blood Center Enterprises [New York / United States of America]
Legacy Pharmaceutical Packaging, LLC - Form 483, 2023-06-30
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: Legacy Pharmaceutical Packaging, LLC [Earth City / United States of America]
Blood Bank Computer Systems, Inc. - Form 483, 2023-06-30
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: Blood Bank Computer Systems, Inc. [Bonney Lake / United States of America]
Dr. Joel Kaplan Inc. - Form 483, 2023-06-30
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: Dr. Joel Kaplan Inc. [San Diego / United States of America]
KEN Hygiene Systems A/S - Form 483, 2023-06-29
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: KEN Hygiene Systems A/S [Broby / Denmark]
Bespak HC Limited - Form 483, 2023-06-27
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: Bespak HC Limited [Crewe / United Kingdom of Great Britain and Northern Ireland]
KEDPLASMA LLC - Form 483, 2023-06-26
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: KEDPLASMA LLC [Sanford / United States of America]
Kendal Nutricare Ltd. - EIR, 2023-08-30
$1190 - Available for instant download
Issued On: June, 2023
Inspection Type: EIR
Site Name: Kendal Nutricare Ltd. [Kendal / United Kingdom of Great Britain and Northern Ireland]
Neuralink Corporation - Form 483, 2023-06-22
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: Neuralink Corporation [Fremont / United States of America]
Hmt Medizintechnik Gmbh - Form 483, 2023-06-22
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: Hmt Medizintechnik Gmbh [Maisach / Germany]
Martin Farm - Konrad Martin - Form 483, 2023-06-21
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: Martin Farm - Konrad Martin [Nappanee / United States of America]
Tytek Medical Inc - Form 483, 2023-06-21
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: Tytek Medical Inc [West Chester / United States of America]
Parks Medical Electronics, Inc - Form 483, 2023-06-15
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: Parks Medical Electronics, Inc [Beaverton / United States of America]
Span Packaging Services LLC dba Multi-Pack Solutions - Form 483, 2023-06-15
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: Span Packaging Services LLC dba Multi-Pack Solutions [Greenville / United States of America]
Keith Cattle Co. - Form 483, 2023-06-15
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: Keith Cattle Co. [Allen / United States of America]
Knittle & Frey, LLC - Form 483, 2023-06-15
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: Knittle & Frey, LLC [Williamsport / United States of America]