FDA WARNING_LETTER - LXR Biotech, LLC - January 20, 2023

On July 17, 2023, the FDA issued Warning Letter WL #652756 to LXR Biotech, LLC, following an inspection from January 9 to 20, 2023, at their Rochester Hills, MI facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug product adulterated under 21 U.S.C. 351(a)(2)(B).

The firm's February 3, 2023, response to the FDA 483 was deemed inadequate, as it lacked specific corrective and preventive actions (CAPA) despite stating they no longer manufacture drugs. Key violations included:

1. **Failure to test components:** The firm did not test samples of each component for identity, purity, strength, and quality, nor did they validate supplier test analyses (21 CFR 211.84(d)(1) and 211.84(d)(2)). 2. **Inadequate release testing:** The firm failed to conduct full laboratory determination of satisfactory conformance to final specifications for drug products, including active ingredient identity and strength, prior to release (21 CFR 211.165(a)). 3. **Lack of adequate production and process controls:** The firm failed to establish written procedures for production and process control, including equipment qualification