FDA Inspection 1115024 — N-Molecular, Inc.
The FDA completed an inspection of N-Molecular, Inc. on January 13, 2020 in Colonie, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 13, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Colonie, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17723 | 21 CFR 212.10 | Personnel not qualified |
| 17875 | 21 CFR 212.70(b) | Compendial test procedure |
| 17898 | 21 CFR 212.71(c) | Correction of problems |