FDA Inspection 1268708 — Osmotica Pharmaceutical US LLC
The FDA completed an inspection of Osmotica Pharmaceutical US LLC on May 2, 2025 in Marietta, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 2, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Marietta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |