# FDA 483 - PolyPeptide Laboratories San Diego LLC - May 15, 2025

Source: https://www.keypedia.com/records/483/polypeptide-laboratories-san-diego-llc/2c96d156-aac6-429a-9d93-50d0eab8bf4c

> FDA 483 for PolyPeptide Laboratories San Diego LLC on May 15, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PolyPeptide Laboratories San Diego LLC
- Inspection Date: 2025-05-15
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: PolyPeptide Laboratories San Diego LLC, an API manufacturer, was cited for failing to follow written procedures for cleaning equipment. Specifically, unclean and corroded fume hoods were observed in both manufacturing and quality control labs, with no documentation of weekly cleaning. This indicates a significant lapse in maintaining equipment sanitation and adherence to established protocols.

## Related Officers

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

Company: https://www.keypedia.com/companies/polypeptide-laboratories-san-diego-llc/9434fe37-e287-4a78-893a-9ca45515b552

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