FDA Inspection
Westwood Laboratories, LLC.Westwood Laboratories, LLC. – FDA Inspection, Oct 31, 2024
Record Details
This FDA Inspection record concerns Westwood Laboratories, LLC., with an inspection on October 31, 2024, issued by the Los Angeles District Office, covering human drugs.
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ID · f68f7ff7-df9a-43bb-bd9a-1f8e6d4f59cf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1253079
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.100(a)Absence of Written Procedures
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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 |
| 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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