FDA Inspection 1214455 — SOFIE Co
The FDA completed an inspection of SOFIE Co on Aug 11, 2023 in Totowa, NJ. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 11, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Totowa, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17904 | 21 CFR 212.80(d) | Labeling and product mix-ups |
| 17914 | 21 CFR 212.100(b) | Complaint review |
| 17941 | 21 CFR 212.71(b) | Documentation of Non-Conforming Product Investigation |
| 21376 | 21 CFR 212.30(a) | Orderly handling, prevention of mix-ups, prevention of contamination |