FDA Inspection 1042553 — N-Molecular Inc. d.b.a. SOFIE
The FDA completed an inspection of N-Molecular Inc. d.b.a. SOFIE on February 28, 2018 in Haverhill, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 28, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Haverhill, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17741 | 21 CFR 212.30(b) | Equipment not clean |
| 17742 | 21 CFR 212.30(b) | Equipment not suitable |
| 17743 | 21 CFR 212.30(b) | Equipment procedures overall |
| 17749 | 21 CFR 212.30(a) | Prevention of contamination |
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17812 | 21 CFR 212.50 | Adequate controls (general) |