# FDA 483 - Avantor Performance Materials LLC - November 13, 2024

Source: https://www.keypedia.com/records/483/avantor-performance-materials-llc/c36c61a8-6dbe-4a8c-9d76-cfa0516815d8

> FDA 483 for Avantor Performance Materials LLC on November 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avantor Performance Materials LLC
- Inspection Date: 2024-11-13
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: The FDA inspected Avantor Performance Materials LLC in Paris, KY, a repacker of APIs and excipients, and identified significant deficiencies. The observations highlight issues with laboratory controls, inadequate investigation of discrepancies, poor equipment cleaning and maintenance, and unsanitary facility conditions. These findings indicate a lack of adherence to good manufacturing practices, which could compromise product quality and purity.

## Related Documents

- [EIR - 2021-04-14](https://www.keypedia.com/records/eir/avantor-performance-materials-llc/ac9577e7-28e9-4e7d-8e7f-d36351c00ad7)
- [483 - 2021-04-14](https://www.keypedia.com/records/483/avantor-performance-materials-llc/d869d731-a48e-4ead-8252-d71f046cf0b1)

## Related Officers

- [Paranthaman Senthamarai Kannan](https://www.keypedia.com/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)
- [Olumide A. Akinyemi](https://www.keypedia.com/people/olumide-a-akinyemi/a520acd2-450c-4624-a7af-b871e4fad9c7)

Company: https://www.keypedia.com/companies/avantor-performance-materials-llc/0621b513-0f0f-438c-8d52-81b548eb0501

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22