# FDA 483 - Westwood Laboratories, LLC. - October 31, 2024

Source: https://www.keypedia.com/records/483/westwood-laboratories-llc/b4dc0276-ae5a-4f23-baa6-aa3794100832

> FDA 483 for Westwood Laboratories, LLC. on October 31, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Westwood Laboratories, LLC.
- Inspection Date: 2024-10-31
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Westwood Laboratories, LLC. in Azusa, CA, was inspected and received a Form 483 with six observations. The inspection revealed significant deficiencies in quality control, including inadequate investigations into out-of-specification results, a lack of a comprehensive stability testing program, and insufficient controls over computer systems. Additionally, the firm failed to establish adequate process validation, and did not properly test drug product components for identity, purity, strength, and quality.

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## Related Officers

- [Navneet Kaur](https://www.keypedia.com/people/navneet-kaur/23db67cc-7589-46f9-bbb9-930c0460500f)
- [Stephon D. Tillis](https://www.keypedia.com/people/stephon-d-tillis/32a4b5de-0dcc-4233-b7c8-b25cf691a138)
- [Stephen D D'illio](https://www.keypedia.com/people/stephen-d-dillio/42302290-db38-4c82-a8b8-0062e31bc115)
- [Gloria E. Andia](https://www.keypedia.com/people/gloria-e-andia/50f145fd-5e25-4a02-bc59-364bcb02b9c8)
- [Regulatory Affairs Specialist](https://www.keypedia.com/people/andrew-le/573464c0-de29-4f64-ab33-62543b7fe719)

Company: https://www.keypedia.com/companies/westwood-laboratories-llc/4deeeece-257e-4b87-aa33-feb6b8f902dd

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b