FDA Inspection
Westwood Laboratories, LLC.Westwood Laboratories, LLC. – FDA Inspection, Feb 25, 2015
Record Details
This FDA Inspection record concerns Westwood Laboratories, LLC., with an inspection on February 25, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Westwood Laboratories, LLC.
- Inspection Date
- February 25, 2015
- Product Type
- Drugs
View Company Profile
ID · f1a98bfd-d6fb-4ef3-a31f-95269695a17d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 916430
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Westwood Laboratories, LLC.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| March 26, 2026 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| October 31, 2024 | OAI | Los Angeles District Office | Drug Quality Assurance |
| November 20, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 5, 2022 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| August 2, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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