FDA 483 - LIFECYCLE BIOTECHNOLOGIES, LP - June 23, 2023

LIFECYCLE BIOTECHNOLOGIES, LP in Cleburne, TX, was cited for significant deficiencies in quality assurance, laboratory controls, and equipment management during an inspection of its PET drug manufacturing facility. Observations included failures to follow written procedures, unsuitable analytical methods, unqualified equipment, and release of out-of-specification product. These issues indicate a lack of robust quality systems that could impact product identity, strength, quality, or purity.