# FDA 483 - Westwood Laboratories, LLC. - May 30, 2019

Source: https://www.keypedia.com/records/483/westwood-laboratories-llc/0c39e719-05fe-415b-9538-8c75acbcf4ae

> FDA 483 for Westwood Laboratories, LLC. on May 30, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Westwood Laboratories, LLC.
- Inspection Date: 2019-05-30
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Westwood Laboratories, Inc. in Azusa, CA, received a Form 483 citing three observations related to laboratory controls and data integrity during an inspection from May 13-30, 2019. The observations highlight issues with computer system controls, including lack of user roles and data discrepancies, as well as inadequate microbiological testing procedures and unauthorized retesting of drug products. These findings indicate significant concerns regarding the firm's quality control and data management practices.

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## Related Officers

- [https://www.fda.gov/media/120628/download](https://www.keypedia.com/people/santiago-gallardo-johnson/f5086b0c-c8fc-44dd-8d12-6506b9dd313f)

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6