Findings citing 21 CFR 211.67

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). You failed to demonstrate that your cleaning practices are adequate to remove potential contaminants and to prevent drug product carry over in shared equipment used to manufacture your OTC drug products. For example, your cleaning validation program for the non-dedicated Unit (b)(4) Line (b)(4) relied exclusively on the visual inspection of…

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated (21 CFR 211.22(a)). The records and information you provided demonstrate that…

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment; and failed to perform operations within specifically defined areas of adequate size; and failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.67(b) and 21 CFR 211.42(c)). During our inspection, we observed inadequate cleaning and inadequate contamination control throughout your…

Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d). You lacked a quality unit (QU) with appropriate oversight for the manufacture of your drug products, and you did not have written quality procedures. Your firm has one SOP that does not adequately govern quality processes for CGMP. For example, you failed to ensure the following…

You failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. You also failed to establish written procedures for cleaning and maintenance of equipment (21 CFR 211.67(a) and 211.67(b)). You…