Findings citing 21 CFR 211.186

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). You lacked a quality unit (QU) with appropriate oversight for the manufacture of your over-the-counter (OTC) topical analgesic drug product. For example, your QU failed to ensure: Adequate procedures were written and followed describing the…

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) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure: Adequate procedures describing roles and responsibilities of the QU, including the handling of vendor…

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) did not adequately oversee your drug manufacturing operations. For example, your QU failed to ensure: Performance of periodic (i.e., at least annually) product reviews for all of your drug products (21 CFR 211.180(e)). Use…

Your firm failed to establish and follow written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch. Your firm also failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.186(a) and 211.188). You did not prepare adequate master and batch production records for your drug product, Magic Heal…