FDA 483 - Anesis Life, LLC - January 29, 2026

Anesis Life, LLC, a drug substance manufacturer in Macomb, MI, was cited with seven observations during an FDA inspection. The inspection revealed significant deficiencies in quality unit oversight, including inadequate supplier evaluation, release of out-of-specification API products, incomplete batch records, lack of process and cleaning validation, insufficient employee training, and poor complaint handling. These issues indicate a systemic failure to adhere to CGMP principles in the manufacturing and control of active pharmaceutical ingredients and homeopathic drug products.