FDA Inspection 1076429 — SOFIE Co.
The FDA completed an inspection of SOFIE Co. on Jan 15, 2019 in Dallas, TX. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 15, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17812 | 21 CFR 212.50 | Adequate controls (general) |
| 17865 | 21 CFR 212.60(g)(5) | Initials, signature, date |
| 17886 | 21 CFR 212.70(e) | When 30 hour rule is exceeded |
| 21376 | 21 CFR 212.30(a) | Orderly handling, prevention of mix-ups, prevention of contamination |