FDA Inspection
Gynex CorporationGynex Corporation – FDA Inspection, Mar 10, 2009
Record Details
This FDA Inspection record concerns Gynex Corporation, with an inspection on March 10, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Gynex Corporation
- Inspection Date
- March 10, 2009
- Product Type
- Drugs
View Company Profile
ID · 480b0cf7-9d2f-4ab7-9b79-fcb8edf4ba15
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 569178
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.122(c)Records fail to include
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 211.122(a)Written procedures describing in detail
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Other FDA inspections of Gynex Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 6, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 27, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 25, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 21, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 20, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Gynex Corporation
- FDA Inspection 1114673 - 2020-01-06
- FDA Inspection 975324 - 2016-05-27
- FDA Inspection 876242 - 2014-04-25
- FDA Inspection 800085 - 2012-09-21
- FDA Inspection 791097 - 2012-07-20
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