FDA Inspection
Westwood Laboratories, LLC.Westwood Laboratories, LLC. – FDA Inspection, May 30, 2019
Record Details
This FDA Inspection record concerns Westwood Laboratories, LLC., with an inspection on May 30, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f93ea951-fbab-4743-8f41-18d017408226
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1091187
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.160(a)Lab controls established, including changes
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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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