FDA Inspection
Westwood Laboratories, LLC.Westwood Laboratories, LLC. – FDA Inspection, Mar 26, 2026
Record Details
This FDA Inspection record concerns Westwood Laboratories, LLC., with an inspection on March 26, 2026, issued by the Los Angeles District Office, covering human drugs.
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ID · 4e8f3f5d-69bb-4794-bb89-ff80afdf86ac
Inspection Facts
- Inspection number
- 1309466
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(2)Laboratory Test Method Verification
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(d)(1)Component identity verification
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Other FDA inspections of Westwood Laboratories, LLC.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| May 30, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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