FluoroMed Products, L.P.March 14, 2025

FDA 483 - FluoroMed Products, L.P. - March 14, 2025

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Record Details

An FDA inspection of FluoroMed Products, L.P. in Round Rock, TX, an API manufacturer, revealed significant cGMP deficiencies. The firm failed to adequately evaluate and establish formal agreements with contract laboratories used for API testing. Additionally, the inspection found a lack of proper procedures for manual integration of gas chromatographs, impacting the quality and purity of manufactured APIs.

Company: FluoroMed Products, L.P.
Inspection Date: March 14, 2025
Product Type: Drugs
Office: Dallas District Office
Person: Timothy H. Vo (investigator)

Open in Dashboard

ID · decb1953-7c34-47eb-93c1-debb8e079ca5