FDA Inspection 1276824 — Sofie Co
The FDA completed an inspection of Sofie Co on Jul 25, 2025 in Sterling, VA. 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
- Jul 25, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sterling, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17877 | 21 CFR 212.70(c) | Conform to specs prior to release |