FDA Inspection 1249609 — Gregory Pharmaceutical Holdings Inc.
The FDA completed an inspection of Gregory Pharmaceutical Holdings Inc. on September 20, 2024 in Bristol, TN. 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
- September 20, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bristol, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |