# FDA 483 - BRS Analytical Services, LLC - March 26, 2025

Source: https://www.keypedia.com/records/483/brs-analytical-services-llc/a08e7755-f310-4d9f-9eeb-f5b976fead34

> FDA 483 for BRS Analytical Services, LLC on March 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BRS Analytical Services, LLC
- Inspection Date: 2025-03-26
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: BRS Analytical Services, LLC, a drug manufacturer in Saint Louis, MO, was inspected by the FDA, revealing significant deficiencies across its sterile drug product manufacturing operations. The firm failed to maintain adequate aseptic processing environments, validate critical processes like sterilization and media fills, and establish robust laboratory controls. Furthermore, the quality control unit demonstrated systemic failures in oversight, record-keeping, and adherence to fundamental GMP principles.

## Related Documents

- [WARNING_LETTER - 2025-03-26](https://www.keypedia.com/records/warning_letter/brs-analytical-services-llc/fc3bbd24-8308-47f8-8168-be4655ba585e)

## Related Officers

- [Matthew M. Schuckmann](https://www.keypedia.com/people/matthew-m-schuckmann/69dd0728-6b5d-41e7-834c-416e25a977dc)
- [Consumer Safety Officer](https://www.keypedia.com/people/eric-d-bowles/bb6c783b-0933-4231-b79e-c591cbc50104)

Company: https://www.keypedia.com/companies/brs-analytical-services-llc/841b237e-76fe-4854-a862-802339b3e528

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79