FDA Inspection 1235513 — Univar Solutions, LLC.
The FDA completed an inspection of Univar Solutions, LLC. on Apr 12, 2024 in Commerce, 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
- Apr 12, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Commerce, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 21296 | 21 CFR 211.186(a) | Master production and control records, batch uniformity |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |