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)).
The electronic data systems that you use to generate drug product results lack appropriate controls. There is no assurance that your systems have the appropriate controls to prevent deletion of data and record all modifications to data. For example, electronic data files generated from your [redact] system, used for identity testing of drug products, could be deleted. In addition, the [redact] that controls your high-performance liquid chromatography and gas chromatography systems for testing the actives in OTC drug products did not have all appropriate audit trails enabled to record significant changes.
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