FDA 483 - Specialty Formulations & Manufacturing, LLC - February 20, 2019

An FDA inspection of Specialty Formulations & Manufacturing, LLC in Phoenix, AZ, revealed significant deficiencies across its drug manufacturing operations. The firm failed to ensure drug product quality through inadequate testing, lack of stability programs, and poor component control. Key issues included the absence of a functional quality control unit, insufficient equipment cleaning and maintenance procedures, and deficient production controls and batch records.