Findings citing 21 CFR 211.170

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…

Your firm failed to retain an appropriately identified reserve sample that is representative of each lot or batch of drug product [21 CFR 211.170(b)]. For example, according to your Chief Strategist, your firm discontinued manufacturing your Regener-Eyes® product containing amniotic fluid in approximately June 2021. Given that this product had a labeled two-year expiration date, any batches that your firm manufactured in June 2021 would have expired in June 2023 based on…

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) lacked adequate control over your OTC drug manufacturing operations and failed to ensure that you had adequate procedures. For example, your QU failed to ensure: Adequate validation of manufacturing processes for ethyl…

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 a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer), labeled as PROTON ARMOR ANTI-MICROBIAL ALCOHOL-FREE FOAMING HAND SANITIZER. 1 Your quality unit (QU) approved the active…