FDA Inspection 1086261 — Gregory Pharmaceutical Holdings Inc.
The FDA completed an inspection of Gregory Pharmaceutical Holdings Inc. on April 12, 2019 in Bristol, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 12, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bristol, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |