FDA 483 - Haney, Inc. - October 18, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · b5cecf5e-8eed-4c9c-a8e6-7d542baf361d