Safecor Health, LLC — FDA Warning Letter Findings

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). Your firm lacks adequate cleaning and maintenance procedures for your equipment used to manufacture your drug products. During the inspection, our investigators observed unidentified white powder residue on non-dedicated product contact surfaces of (b)(4) used for packaging tablets that were held to be in “clean status.” Furthermore, your 2019…

Your firm does not adequately inspect the packaging and labeling facilities immediately before use to assure that all drug products have been removed from the previous operations (21 CFR 211.130(e)). Your firm operates as a drug manufacturer and repackager. You failed to implement adequate controls to prevent mix-ups, and to assure that all materials not suitable for subsequent operations have been removed. During the inspection, our investigators observed a variety of…

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your quality unit (QU) failed to ensure adequate document control over paper records. For example, our investigators observed partially completed and torn-up manufacturing records for a lot of children’s acetaminophen and stacks of loose printed…

Your firm failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(2)). You use water as a component in your drug products. Your firm failed to test incoming components including (b)(4) water USP and (b)(4) water used to manufacture prescription drug products to determine their identity, purity, strength, and other appropriate quality attributes. During the inspection, you informed…