# FDA 483 - PolyPeptide Laboratories, Inc. - May 10, 2024

Source: https://www.keypedia.com/records/483/polypeptide-laboratories-inc/ba06b162-f067-4036-abb1-01c2e728f3fa

> FDA 483 for PolyPeptide Laboratories, Inc. on May 10, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PolyPeptide Laboratories, Inc.
- Inspection Date: 2024-05-10
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: PolyPeptide Laboratories Inc. in Torrance, CA, an API manufacturer, was cited for significant deficiencies in its cleaning validation processes. The firm's Cleaning Process Performance Qualifications Protocols and Reports (CPPQ) were found to be insufficient, lacking scientific justification, containing questionable data reporting, and failing to adequately justify established dirty hold times. These issues indicate a lack of robust control over equipment cleaning practices for commercial and non-commercial API batches.

## Related Documents

- [483 - 2019-08-30](https://www.keypedia.com/records/483/polypeptide-laboratories-inc/b5e10f52-9c04-4a4d-8237-3a02d497c9b9)
- [EIR - 2021-11-19](https://www.keypedia.com/records/eir/polypeptide-laboratories-inc/19c17707-3c4a-4370-88b5-950e514b5073)

## Related Officers

- [Chemist/Investigator - Pharmaceutical Quality](https://www.keypedia.com/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Regulatory Affairs Specialist](https://www.keypedia.com/people/andrew-le/573464c0-de29-4f64-ab33-62543b7fe719)
- [Matthew R. Clabeaux](https://www.keypedia.com/people/matthew-r-clabeaux/9acc9b47-4063-4582-ac9a-983a07079495)
- [Anmey Lin](https://www.keypedia.com/people/anmey-lin/b01ca905-fab9-465e-acd6-901bc51edd2d)
- [Jay-Ar C. Bendo](https://www.keypedia.com/people/jay-ar-c-bendo/c920c6b7-756b-42c7-be52-8b677d192f77)

Company: https://www.keypedia.com/companies/polypeptide-laboratories-inc/9d05664c-4a42-45cc-81f6-ef85c356ecc1

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