FDA Inspection 569178 — Gynex Corporation
The FDA completed an inspection of Gynex Corporation on March 10, 2009 in Redmond, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 10, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Redmond, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4327 | 21 CFR 211.122(c) | Records fail to include |