FDA Inspection 1227438 — Sofie Co.
The FDA completed an inspection of Sofie Co. on Jan 22, 2024 in Sanford, FL. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 22, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sanford, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17723 | 21 CFR 212.10 | Personnel not qualified |
| 17812 | 21 CFR 212.50 | Adequate controls (general) |
| 21376 | 21 CFR 212.30(a) | Orderly handling, prevention of mix-ups, prevention of contamination |