FDA Inspection 982488 — SOFIE Co.
The FDA completed an inspection of SOFIE Co. on Aug 4, 2016 in Gilroy, CA. 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 4, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gilroy, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17897 | 21 CFR 212.71(b) | Investigation of nonconforming product |