# FDA 483 - Brighton Laboratory - August 21, 2025

Source: https://www.globalkeysolutions.net/records/483/brighton-laboratory/44678a06-9a3c-442a-9552-ceef9569cf00

> FDA 483 for Brighton Laboratory on August 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brighton Laboratory
- Inspection Date: 2025-08-21
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: Optimal Solutions Inc dba Brighton Laboratory, a contract testing laboratory in Las Vegas, NV, was cited for significant quality control deficiencies during an FDA inspection from August 19-21, 2025. The firm's quality unit lacked written procedures and adequate control over documents related to OTC drug testing. Issues included using unvalidated programs for calculations, poor documentation practices in microbiology logbooks, and insufficient audit trail review for HPLC software.

## Related Officers

- [Cecilia H. Kieu](https://www.globalkeysolutions.net/people/cecilia-h-kieu/3ba5feb0-d49e-4301-ae5c-b84bd604a159)

Company: https://www.globalkeysolutions.net/companies/brighton-laboratory/7b9543dc-6111-4408-be79-4086d1309969

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df