483
FluoroMed Products, L.P.FDA 483 - FluoroMed Products, L.P. - March 14, 2025
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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.
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ID · decb1953-7c34-47eb-93c1-debb8e079ca5