FDA Inspection 1237161 — Olympia Pharmaceuticals
The FDA completed an inspection of Olympia Pharmaceuticals on May 29, 2024 in Orlando, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 29, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 22779 | FDCA 503B(b)(2)(A) | All inclusive product report, not submitted |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |