Findings citing 21 CFR 211.130

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 firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacture of drug products. For example, you failed to ensure: Adherence to an adequate stability program (21 CFR 211.166(a))…

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 firm manufactures over-the-counter (OTC) hand rub drug products (also referred to as a consumer hand sanitizer) including PureCareRx Liquid Hand Sanitizer (0.1% benzalkonium chloride). Your firm failed to establish a quality unit (QU) to…

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 firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacture of drug products. For example, you failed to ensure: An adequate complaint handling process (21 CFR 211.198)…

Other CGMP Noncompliance Your affidavit also demonstrated that your facility was not in compliance with other applicable CGMP requirements including the following: You failed to establish and follow written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). You failed to establish and follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile (21 CFR 211.113(a)). You did not keep…