Findings citing 21 CFR 211.68

Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your firm lacked sufficient controls over your gas chromatography (GC) instrument used to test components in your finished drug products. Your GC laboratory instrument was not adequately qualified because you failed to validate the control software or enable…

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 exercise its authority and responsibilities including, but not limited to, implementing effective procedures and conducting adequate oversight of the drug products you manufacture. For example, your QU…

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 manufacturing of drug products. For example, your QU failed to ensure: Establishment of adequate batch production and control…

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 product manufacturing operations and failed to ensure that you had adequate procedures. For example, your quality unit (QU) failed to ensure the following: Establishment of…

Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your laboratory equipment lacked sufficient controls to prevent and detect deletion or manipulation of your laboratory's electronic raw data. For example, your ultraviolet-visible (UV-vis) and infrared (IR) spectroscopy equipment was found to lack…

Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your firm lacked sufficient controls over your liquid chromatography (LC) and gas chromatography (GC) instrument used to test drug products prior to release. Specifically, your firm did not appropriately control administrative privileges for file…