# FDA 483 - Aprecia Pharmaceuticals LLC - March 21, 2025

Source: https://www.globalkeysolutions.net/records/483/aprecia-pharmaceuticals-llc/872a89c8-17d0-4e8b-a560-8ab3746a4e2a

> FDA 483 for Aprecia Pharmaceuticals LLC on March 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aprecia Pharmaceuticals LLC
- Inspection Date: 2025-03-21
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: The FDA inspected Aprecia Pharmaceuticals, LLC in Mason, OH, and issued a Form 483 with two observations. The inspection revealed deficiencies in component testing, specifically lacking specific identification tests for drug product components, and issues with laboratory records where analysts could manipulate data in Empower software without saving chromatograms. These issues indicate potential concerns with product quality and data integrity.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)
- [Martin M. Kimani](https://www.globalkeysolutions.net/people/martin-m-kimani/fbc296cc-e80e-46f4-a34a-848c8b20da05)

Company: https://www.globalkeysolutions.net/companies/aprecia-pharmaceuticals-llc/126049a3-6c3d-4616-8d44-006827a308c3

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22