FDA Inspection 1168736 — Westwood Laboratories, LLC.
The FDA completed an inspection of Westwood Laboratories, LLC. on Apr 5, 2022 in Azusa, 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 5, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Azusa, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |