FDA 483 - Haney, Inc. - October 18, 2022

Haney Inc., a repacker and relabeler in Cincinnati, OH, was cited for significant deficiencies during an FDA inspection. The firm failed to adequately investigate batch failures and environmental monitoring excursions, did not consistently follow written production and process control procedures, and maintained deficient batch production records. Additionally, the inspection revealed a lack of appropriate controls over computer systems, compromising data integrity for investigation results.