FDA EIR - Genus Lifesciences Inc. - September 29, 2017

Genus Lifesciences Inc., a manufacturer of controlled and non-controlled drug products in Allentown, PA, underwent a full cGMP surveillance inspection by the FDA from September 25-29, 2017. The inspection, conducted under Title 21 of the Code of Federal Regulations (21 CFR) Part 210 & 211, identified significant deficiencies in their quality control and operational systems. At the inspection's conclusion, the company received a two-item FDA-483. The primary violations included incomplete laboratory records, specifically the omission of data from test injections, lack of documented audit trail reviews for electronic data, and inadequate validation of Excel spreadsheets used for calculations. A critical concern was the absence of appropriate controls over computer systems, demonstrated by an analyst's ability to delete raw data files from an FT-IR instrument. Verbally discussed issues included inconsistent adherence to change control procedures, failure to establish "dirty hold time" during cleaning validation, and unresolved consumer complaints regarding cloudy Potassium Chloride oral solution due to precipitation. The company acknowledged these observations and was directed to submit a written response detailing corrective actions to the FDA within fifteen business days.