# FDA 483 - Westridge Laboratories Inc - December 29, 2025

Source: https://www.keypedia.com/records/483/westridge-laboratories-inc/1dcce1f9-cd4a-4215-8fe6-83eae992b55a

> FDA 483 for Westridge Laboratories Inc on December 29, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Westridge Laboratories Inc
- Inspection Date: 2025-12-29
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Westridge Laboratories Inc. in Santa Ana, CA, revealed significant deficiencies in their quality system for medical devices. Observations included inadequate corrective and preventive action procedures, failure to apply Unique Device Identifiers (UDI) on product labels, and incomplete information in the Global Unique Device Identification Database (GUDID). Additionally, the firm's design input procedures were found to be inadequately established.

## Related Documents

- [483 - 2023-01-18](https://www.keypedia.com/records/483/westridge-laboratories-inc/f3c96e6f-9f26-455d-82d2-e581e953ce40)

## Related Officers

- [Jae H. Lee](https://www.keypedia.com/people/jae-h-lee/ce701294-2a54-48f2-8a34-e93231bc2d88)

Company: https://www.keypedia.com/companies/westridge-laboratories-inc/342e0eb1-1bc3-4619-9d4a-842a82f4c536

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