FDA Inspection 1195181 — SOFIE Co.
The FDA completed an inspection of SOFIE Co. on Jan 20, 2023 in Somerset, NJ. 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 20, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Somerset, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17763 | 21 CFR 212.20(d) | Determination need for investigation |
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17812 | 21 CFR 212.50 | Adequate controls (general) |
| 17855 | 21 CFR 212.60(e) | Equipment |
| 17874 | 21 CFR 212.70(b) | Before implementing new procedure establish and document accuracy etc. |
| 17898 | 21 CFR 212.71(c) | Correction of problems |
| 17913 | 21 CFR 212.100(a) | Written complaint procedures |
| 21373 | 21 CFR 212.30(b) | Equipment procedures |