FDA 483 - TECHNICHEM CORP - April 28, 2025

CDL Services, Inc. in Anaheim, CA, received a Form 483 with eight observations, many of which were repeats from prior inspections. The inspection revealed severe deficiencies across quality control, production, and equipment systems, including a complete absence of a quality control unit, inadequate product testing, and unvalidated processes and equipment for OTC drug manufacturing. These issues indicate a systemic failure to adhere to good manufacturing practices, raising significant concerns about the safety, identity, strength, quality, and purity of their drug products.