# FDA 483 - Reliable Biopharmaceutical LLC - February 21, 2020

Source: https://www.globalkeysolutions.net/records/483/reliable-biopharmaceutical-llc/a3fc4551-5840-43a2-b3fb-de9bf16b5131

> FDA 483 for Reliable Biopharmaceutical LLC on February 21, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reliable Biopharmaceutical LLC
- Inspection Date: 2020-02-21
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Reliable Biopharmaceutical LLC, an API manufacturer in Overland, MO, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate investigations and corrective actions, failure to calibrate equipment, deficient personnel training, non-compliance with reference standard procedures, insufficient data integrity controls for computerized systems, and poor building maintenance. These issues indicate a moderate level of non-compliance with GMP regulations.

## Related Documents

- [483 - 2025-08-20](https://www.globalkeysolutions.net/records/483/reliable-biopharmaceutical-llc/46fdca63-d9b6-4ee4-ba19-f830c880c97a)

## Related Officers

- [Regulatory Officer ](https://www.globalkeysolutions.net/people/jill-tillman/4fd81eed-0de2-468b-a776-d4809fa91553)
- [Investigator](https://www.globalkeysolutions.net/people/michele-perry-williams/80741e95-8df3-41c9-b9b8-499fcb97921d)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8