FDA Inspection 1305568 — Neilmed Pharmaceuticals Inc
The FDA completed an inspection of Neilmed Pharmaceuticals Inc on Jul 22, 2026 in Santa Rosa, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 22, 2026
- Fiscal Year
- 2026
- 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 |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |