FDA 483 - TECHNICHEM CORP - March 18, 2020

TECHNICHEM CORP in Anaheim, CA, was inspected and received a Form 483 with eight observations indicating significant deficiencies in their drug manufacturing processes. Key issues include inadequate environmental controls, lack of component testing and vendor qualification, unsupported product stability data, and incomplete batch records. The firm also failed to establish and follow procedures for quality control decisions, complaint handling, annual product reviews, and process validation.