FDA Inspection 1314718 — Samson Pharmaceuticals, Inc
The FDA completed an inspection of Samson Pharmaceuticals, Inc on Apr 29, 2026 in Commerce, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 29, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Commerce, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4576 | 21 CFR 211.192 | No written record of investigation |