FDA Inspection 1279428 — SOFIE Co.
The FDA completed an inspection of SOFIE Co. on August 7, 2025 in Gilroy, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 7, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gilroy, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17723 | 21 CFR 212.10 | Personnel not qualified |
| 17882 | 21 CFR 212.70(d)(2) | Data and documentation review |
| 21373 | 21 CFR 212.30(b) | Equipment procedures |