FDA Inspection 1282808 — PTI Georgia, LLC
The FDA completed an inspection of PTI Georgia, LLC on January 16, 2026 in Royston, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 16, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Royston, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |