# FDA 483 - Avantor Performance Materials LLC - April 14, 2021

Source: https://www.keypedia.com/records/483/avantor-performance-materials-llc/d869d731-a48e-4ead-8252-d71f046cf0b1

> FDA 483 for Avantor Performance Materials LLC on April 14, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avantor Performance Materials LLC
- Inspection Date: 2021-04-14
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Avantor Performance Materials LLC, a repacker in Paris, KY, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in equipment and utensil maintenance, inadequate record-keeping for maintenance activities, and a lack of proper secondary review for cleaning and maintenance logs. These issues indicate a failure to ensure the safety, identity, strength, quality, or purity of drug products.

## Related Documents

- [EIR - 2021-04-14](https://www.keypedia.com/records/eir/avantor-performance-materials-llc/ac9577e7-28e9-4e7d-8e7f-d36351c00ad7)
- [483 - 2024-11-13](https://www.keypedia.com/records/483/avantor-performance-materials-llc/c36c61a8-6dbe-4a8c-9d76-cfa0516815d8)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)
- [Jon P. Antoniou](https://www.keypedia.com/people/jon-p-antoniou/e42f4f7d-dbdb-4d85-a755-92cb29c249bc)

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