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

Source: https://www.keypedia.com/records/483/avantor-performance-materials-llc/d03c60a6-80f0-453b-bfcc-80d8fda8a9df

> 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: An FDA inspection conducted from November 6-13, 2024, at Avantor Performance Materials LLC, a repacker in Paris, KY, identified significant deviations from Good Manufacturing Practices (GMP). The observations outlined in the Form FDA 483 highlight critical issues across laboratory controls, quality system investigations, equipment maintenance, and facility sanitation.Specifically, laboratory control deficiencies included a lack of oversight on data entry forms, uninvestigated equipment malfunctions, unauthorized modification of analytical parameters, and inadequate electronic raw data review. The firm also failed to thoroughly investigate numerous discrepancies, such as product contamination and uncalibrated gauges, with many quality events remaining open since 2021. Critical repeat observations from a 2021 inspection noted missing verification signatures in cleaning and production logs, and operators failing to contemporaneously document actions. Further concerns involved inadequate equipment maintenance, including a dishwasher not meeting validated temperatures, and unmanaged hose usage. Facility sanitation issues included standing water and rust in production areas, alongside insufficient cleaning times documented for product changeovers.Avantor Performance Materials LLC is required to promptly address these serious observations, implement robust corrective and preventive actions, and ensure full compliance with FDA regulations to safeguard product quality and patient safety.

## Related Documents

- [483 - 2021-04-14](https://www.keypedia.com/records/483/avantor-performance-materials-llc/d869d731-a48e-4ead-8252-d71f046cf0b1)
- [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)

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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