# Reliable Biopharmaceutical LLC – FDA 483, Aug 20, 2025

Source: https://www.keypedia.com/records/483/reliable-biopharmaceutical-llc/46fdca63-d9b6-4ee4-ba19-f830c880c97a

> FDA 483 for Reliable Biopharmaceutical LLC on August 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reliable Biopharmaceutical LLC
- Inspection Date: 2025-08-20
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: An FDA inspection of Reliable Biopharmaceutical LLC in Overland, MO, identified a significant issue with the firm's process water system. The inspection revealed inadequate maintenance and operation, specifically an apparent water leak, which compromises the suitability of water used in manufacturing nonsterile Active Pharmaceutical Ingredients (API) intended for sterile drug products. This indicates a potential risk to product quality and patient safety.

## Related Documents

- [483 - 2020-02-21](https://www.keypedia.com/records/483/reliable-biopharmaceutical-llc/a3fc4551-5840-43a2-b3fb-de9bf16b5131) — date: February 21, 2020

## Related Officers

- [Matthew M. Schuckmann](https://www.keypedia.com/people/matthew-m-schuckmann/69dd0728-6b5d-41e7-834c-416e25a977dc)

Company: https://www.keypedia.com/companies/reliable-biopharmaceutical-llc/c2c29fa4-55fa-4f4e-9da7-622d595d395b

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