FDA Inspection
Patrin Pharma, Inc.Patrin Pharma, Inc. – FDA Inspection, Aug 19, 2014
Record Details
This FDA Inspection record concerns Patrin Pharma, Inc., with an inspection on August 19, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Patrin Pharma, Inc.
- Inspection Date
- August 19, 2014
- Product Type
- Devices
View Company Profile
ID · 647df0c9-4a7a-4bbc-b6ab-f01c7ae4b0e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 894524
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Patrin Pharma, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 6, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 7, 2017 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| January 5, 2009 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Patrin Pharma, Inc.
- FDA Inspection 1181664 - 2022-10-18
- FDA Inspection 1088650 - 2019-05-06
- FDA Inspection 1039377 - 2017-11-07
- FDA Inspection 554449 - 2009-01-05
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