FDA 483 - Pet Apothecary Llc - July 24, 2025

An FDA inspection of Mixlab WI LLC in Milwaukee, a producer of non-sterile drug products, revealed significant deficiencies in quality control and manufacturing practices. The firm failed to consistently follow written procedures for compounding and cleaning, maintain complete batch production records, and adequately test drug products for potency and stability. These issues indicate a lack of adherence to established good manufacturing practices.