FDA Inspection 1040504 — Samson Pharmaceuticals, Inc
The FDA completed an inspection of Samson Pharmaceuticals, Inc on February 9, 2018 in Commerce, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 9, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Commerce, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1430 | 21 CFR 211.42(c)(10)(i) | Floors, walls, ceiling surfaces |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4356 | 21 CFR 211.166(b) | Tentative expiration date |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |