Findings citing 21 CFR 211.101

Your firm failed to establish adequate written production and control procedures for the charge-in of components designed to assure that the drug products produced have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.101). You failed to formulate your drug products with the intent to provide no less than 100% of the declared active ingredient. For example, your EREWHON drug products, EREWHON ANTIBACTERIAL SPRAY and EREWHON…

Your firm failed to formulate batches of your drug product with the intent to provide not less than 100% of the labeled or established amount of active ingredient (21 CFR 211.101(a)). Your firm failed to ensure that your (b)(4) wipe drug products were formulated to contain the (b)(4) active ingredient at the labeled strength of (b)(4) %. Drug products must be formulated to contain the amount of active ingredient they are represented to possess. In your response, you…

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…