FDA 483 - Best Formulations Inc - September 30, 2021

Best Formulations Inc, a drug manufacturer in City Of Industry, CA, was cited for failing to establish and follow written procedures for equipment cleaning and maintenance during an FDA inspection from September 27-30, 2021. Inspectors observed unknown stains and residues on cleaning tanks without logs, an unlabeled tank of scrap softgels, and incomplete cleaning records for the Gelatin Color Room. These issues indicate significant deficiencies in maintaining a state of control over manufacturing equipment and processes.