# FDA 483 - PolyPeptide Laboratories Private Limited - November 22, 2024

Source: https://www.keypedia.com/records/483/polypeptide-laboratories-private-limited/f8428a4f-1d64-461d-846f-4b497e10b64b

> FDA 483 for PolyPeptide Laboratories Private Limited on November 22, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PolyPeptide Laboratories Private Limited
- Inspection Date: 2024-11-22
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of PolyPeptide Laboratories Private Limited, an API manufacturer in Ambernath, India, revealed significant deficiencies in the firm's Quality Unit. Observations included inadequate supplier qualification for packaging materials and a failure to timely close multiple deviation investigations according to established procedures. These issues indicate a lack of robust quality control over critical manufacturing processes and documentation.

## Related Officers

- [Investigator](https://www.keypedia.com/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)

Company: https://www.keypedia.com/companies/polypeptide-laboratories-private-limited/bf5a7a5c-b537-4d71-87ce-a45650fd2b07

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8