FDA Inspection 1089718 — N-Molecular Inc. D.B.A. SOFIE
The FDA completed an inspection of N-Molecular Inc. D.B.A. SOFIE on May 16, 2019 in Haverhill, MA. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 16, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Haverhill, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17855 | 21 CFR 212.60(e) | Equipment |