FDA Inspection
Westwood Laboratories, LLC.Westwood Laboratories, LLC. – FDA Inspection, Nov 20, 2023
Record Details
This FDA Inspection record concerns Westwood Laboratories, LLC., with an inspection on November 20, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fe83a942-4297-4271-abad-98fed1fc2cd9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1223194
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(e)Records reviewed annually
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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 |
| 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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