FDA Inspection 1192758 — Neilmed Pharmaceuticals Inc
The FDA completed an inspection of Neilmed Pharmaceuticals Inc on December 2, 2022 in Santa Rosa, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 2, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Rosa, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |