FDA 483 - Addison Biological Laboratory Inc - September 15, 2022

An FDA inspection of Addison Biological Laboratory Inc. in Fayette, MO, an animal drug manufacturer, revealed significant deficiencies in laboratory controls. The firm failed to establish scientifically sound specifications and test procedures for its water system and final drug products, potentially compromising the identity, strength, quality, and purity of its animal drugs. This includes inadequate microbial testing for water and stability samples, and a lack of testing for specific objectionable organisms like Burkholderia cepacia Complex.