Lex Inc. — FDA Warning Letter Findings

Your firm failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of automatic, mechanical, electronic equipment, or other types of equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product. Your firm also failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and…

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’s quality system was inadequate. Your quality unit (QU) did not provide adequate oversight for the manufacture of your over the counter (OTC) drug products. For example, your QU failed to ensure: Adequate oversight, including but not…

Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)). Your firm lacked an adequate process validation program and sufficient validation studies for your drug product…

Your firm failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and released for use by the quality control unit. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(a)…