FDA 483 - Person & Covey Inc - January 30, 2020

Person & Covey Inc, a drug manufacturer in Glendale, CA, was inspected by the FDA from January 28-30, 2020, resulting in six observations. The inspection revealed significant deficiencies including the marketing of unapproved prescription drug products, inadequate container closure systems, and a complete lack of an active stability program. Further issues involved insufficient cleaning validation, an absent environmental monitoring program, and a failure to ensure executive review of internal investigations and FDA inspection reports.