Aprecia Pharmaceuticals LLCMarch 21, 2025

FDA 483 - Aprecia Pharmaceuticals LLC - March 21, 2025

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Aprecia Pharmaceuticals LLC

Record Details

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.

Company: Aprecia Pharmaceuticals LLC
Inspection Date: March 21, 2025
Product Type: Drugs
Office: Cincinnati District Office
People: Rafeeq A. Habeeb (Investigator)
Martin M. Kimani

Open in Dashboard

ID · 872a89c8-17d0-4e8b-a560-8ab3746a4e2a