Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>>
Inspection End Date | Company | City/Local | State/Region | Country |
12/26/13 | Prexion, Inc. | San Mateo | CA | United States |
11/6/13 | Prime Herbs Corporation | Sunnyvale | CA | United States |
12/1/10 | Primrose Candy Co | Chicago | IL | United States |
3/28/12 | Prince Medical | Ercuis | France | |
1/17/14 | Pro Trainers’ Choice Company | Kingston | WA | United States |
11/22/13 | Problem Solving Concepts, Inc | Indianapolis | IN | United States |
9/11/13 | Product Safety Labs | Dayton | NJ | United States |
1/11/13 | Prof. Aleksander B Skotnicki | Krakow | Poland | |
4/3/13 | Promed Exports Private Limited | District Solan, Himachal Pradesh | India | |
1/11/13 | Promethean LifeSciences, Inc. | Pittsburgh | PA | United States |
1/21/14 | Protek Medical Products Inc | Coralville | IA | United States |
3/18/13 | PROXY Laboratories B.V. | Leiden | Netherlands | |
2/24/14 | Pure Source, Inc. | Doral | FL | United States |
8/30/13 | Pyxant Labs, Inc. | Colorado Springs | CO | United States |
9/13/13 | QLasers PMA | Rapid City | SD | United States |
6/21/13 | QPS, LLC | Newark | DE | United States |
6/28/12 | Quantum Herbal Products | Saugerties | NY | United States |
6/9/11 | Questcor Pharmaceuticals, Inc | Hayward | CA | United States |
11/12/13 | Questcor Pharmaceuticals, Inc | Hayward | CA | United States |
12/22/11 | Quincy Bioscience Manufacturing Inc. | Madison | WI | United States |
12/7/11 | Quincy Bioscience Manufacturing Inc. | Middleton | WI | United States |
9/13/13 | R.H. Kaplan Associates, Inc. d/b/a David Scott Company | Framingham | MA | United States |
2/26/14 | Radlink Inc | Gardena | CA | United States |
6/25/13 | Ralf C. Zimmermann | New York | NY | United States |
2/21/14 | Raphe Healthcare Inc. dba Raphe’ Pharmaceutiques | Garland | TX | United States |
10/4/13 | Refine USA, LLC | Jacksonville | FL | United States |
4/15/14 | Respironics, Inc. | Murrysville | PA | United States |
2/20/14 | Richard Casaburi | Torrance | CA | United States |
1/23/13 | Richmond University Medical Center | Staten Island | NY | United States |
12/2/13 | Riverpoint Medical, LLC | Portland | OR | United States |
11/12/13 | Rockford Specialties | Loves Park | IL | United States |
11/8/13 | Rocky Mountain Research, Inc. | Salt Lake City | UT | United States |
12/4/12 | Rosario Hidalgo, MD | Tampa | FL | United States |
2/10/14 | Rowny Systems, Inc. dba Antigen Plus | Bethesda | MD | United States |
2/15/12 | Roy Lester Schneider Hospital | St Thomas | VI | United States |
9/5/13 | Ruemu Birhiray | Indianapolis | IN | United States |
8/20/13 | Ruger Chemical Co. Inc | Linden | NJ | United States |
1/6/14 | S4OPTIK / Rightmedical Products, LLC | Virginia Beach | VA | United States |
1/23/12 | Sagar Lonial, M.D. | Atlanta | GA | United States |
1/15/14 | Sage Products Inc | Cary | IL | United States |
9/10/13 | Saltillo Corp. | Millersburg | OH | United States |
8/14/12 | Sandoz Incorporated | Broomfield | CO | United States |
10/17/13 | Sandoz Incorporated | Broomfield | CO | United States |
9/20/13 | Sanofi Pasteur Limited – Cannaught Campus | North York | Canada | |
4/30/14 | Scale-Tronix Inc | Carol Stream | IL | United States |
12/20/13 | Seatex, Ltd | Rosenberg | TX | United States |
12/13/13 | Semler Technologies Inc. | Portland | OR | United States |
12/1/11 | Serumwerk Bernburg AG | Bernburg (Saale) | Germany | |
12/2/11 | Serumwerk Bernburg AG | Bernburg (Saale) | Germany | |
8/30/13 | Seventh Wave Lab | Chesterfield | MO | United States |
1/21/14 | SGS North America, Inc. | Fairfield | NJ | United States |
3/5/13 | Shamrock Medical Solutions Group LLC | Lewis Center | OH | United States |
2/10/12 | Shanghai Huhui Daily Use Chemical Products Co., Ltd. | Sh | China | |
3/22/13 | Shanghai Life-Beauty Cosmetics Co., Ltd. | Shanghai | China | |
1/15/14 | Sharp Corporation | Allentown | PA | United States |
12/9/13 | Shasta Technologies, LLC | Sherwood | OR | United States |
1/15/13 | Shenzhen Hepalink Pharmaceutical Co., Ltd. | Shenzhen | China | |
5/3/13 | SHILPA MEDICARE LTD | CHIKSUGUR POST RAICHUR | India | |
4/1/14 | Shionogi & Co., Ltd. | Kanegasaki-Cho | Japan | |
6/3/13 | Shire Regenerative Medicine, Inc. | La Jolla | CA | United States |
3/27/09 | Sifavitor SrL | Casaletto Lodigiano | Italy | |
12/9/13 | Sigma-Aldrich Mfg LLC | Saint Louis | MO | United States |
11/7/13 | Sigma-Tau Pharmasource, Inc. | Indianapolis | IN | United States |
12/23/13 | Silarx Pharmaceutical, Inc. | Carmel | NY | United States |
2/5/14 | Sleep Solutions, Inc. | Glen Burnie | MD | United States |
12/17/13 | Smart Medical Technology Inc | Darien | IL | United States |
10/23/13 | SmithKline Beecham (Cork) Ltd. | Cork | Ireland | |
10/18/13 | Smruthi Organics Limited | Solapur District, Maharashtra State | India | |
1/23/14 | Sonivate Medical, Inc. | Beaverton | OR | United States |
8/8/11 | South Texas Blood and Tissue Center | San Antonio | TX | United States |
11/6/13 | Southeast Aesthetic LTD Co | Tallahassee | FL | United States |
6/21/13 | Sovereign Pharmaceuticals, LLC | Fort Worth | TX | United States |
4/2/14 | Spacelabs Healthcare, Llc | Snoqualmie | WA | United States |
1/24/14 | Sparton Medical Systems Colorado | Frederick | CO | United States |
12/6/13 | Spectron MRC, LLC | South Bend | IN | United States |
11/4/13 | Spectrum Laboratories, Inc | Irving | TX | United States |
1/15/14 | Spinal Elements, Inc | Carlsbad | CA | United States |
2/28/14 | SpineNet | Winter Park | FL | United States |
You can obtain these at the FDAzilla 483s store here>>
Other FDA 483 resources of interest:
– Free, searchable FDA Inspections/483s Dashboard, just updated
– FDAzilla Inspection Readiness Toolkit
– More FDA 483 Coverage
– FDA 483 PDF Subscription Service
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence.