LXR Biotech, LLC

Warning LetterOpen

Mr. Andrew H. Krause President and CEO LXR Biotech, LLC 2983 Waterview Dr. Rochester Hills , MI 48309-4600 United StatesFEI 3010744574Issued Jul 17, 2023Division of Pharmaceutical Quality Operations III

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3010744574.

Violations5

Issue DateJul 17, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: LXR Biotech, LLC
Location: Mr. Andrew H. Krause President and CEO LXR Biotech, LLC 2983 Waterview Dr. Rochester Hills , MI 48309-4600 United States
FEI Number: 3010744574
Country: United States
Issue Date: July 17, 2023
Issuing Office: Division of Pharmaceutical Quality Operations III
Product Type: Drugs
Status: Open

Summary

LXR Biotech, LLC, a drug manufacturer in Rochester Hills, Michigan, was found to have produced adulterated pharmaceutical products in violation of Current Good Manufacturing Practice (CGMP) regulations during a January 2023 FDA inspection. The company failed to adequately test drug components for identity, purity, strength, and quality, and did not validate or establish the reliability of component suppliers' test analyses at appropriate intervals, including failure to obtain or review suppliers' certificates of analysis. The FDA determined the firm's response was inadequate because while LXR Biotech stated it no longer manufactures drugs, it provided no specific corrective actions, preventive measures, or commitment to remove affected products from the market.

LXR Biotech, LLC FDA Warning Letter, July 17, 2023