# FDA 483 - Westwood Laboratories, LLC. - April 05, 2022

Source: https://www.keypedia.com/records/483/westwood-laboratories-llc/111b7bb2-f00a-409f-b871-67d67666dde5

> FDA 483 for Westwood Laboratories, LLC. on April 05, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Westwood Laboratories, LLC.
- Inspection Date: 2022-04-05
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Westwood Laboratories, Inc. in Azusa, CA, a contract manufacturer, received a Form 483 with four observations, three of which were repeats. The inspection revealed significant deficiencies in environmental monitoring, data integrity for computer systems, incomplete batch production records, and inadequate change control procedures. These issues indicate a systemic lack of adherence to Good Manufacturing Practices.

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## Related Officers

- [Alan L. Truong](https://www.keypedia.com/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)

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