FDA 483 - Kappa Laboratories, Inc. - April 22, 2022

Kappa Laboratories, Inc. in Miami, FL, a contract test laboratory, was cited for a significant deficiency in its laboratory controls. The inspection revealed that the firm failed to establish scientifically sound test procedures for components, specifically omitting Total Organic Carbon testing for a USP grade component used in media plate production for drug product testing. This indicates a potential risk to the quality and purity assurance of finished drug products.