FDA Inspection 1079123 — SOFIE Co.
The FDA completed an inspection of SOFIE Co. on Feb 5, 2019 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 5, 2019
- Fiscal Year
- 2019
- 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 |
| 17865 | 21 CFR 212.60(g)(5) | Initials, signature, date |
| 17883 | 21 CFR 212.70(d)(3) | Final dated signature |
| 21376 | 21 CFR 212.30(a) | Orderly handling, prevention of mix-ups, prevention of contamination |