Laboratorios Jaloma S.A. de C.V. — FDA Warning Letter Findings

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 failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). You failed to adequately validate your alternative microbial methods used to test drug products to…

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 QU lacked adequate oversight and control over your OTC drug product manufacturing operations to ensure state of control and adherence to all quality standards. Significant findings in this letter demonstrate that your firm does not operate…

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). You failed to accurately document microbiology sampling and testing results for components used in your over-the-counter (OTC) drug products. Your laboratory records did not accurately reflect activities performed. For example, your microbiologist documented the collection of routine…