FDA EIR - Veridian Healthcare - November 28, 2018

An FDA inspection of Veridian Healthcare, an own-label distributor of OTC topical analgesic drug products and medical devices located in Gurnee, IL, was conducted from November 15-28, 2018. This initial cGMP inspection, focusing on quality, facilities, equipment, materials, and production systems, resulted in a 5-observation FDA Form 483. The inspection revealed significant deficiencies in the company's quality management system. Veridian Healthcare's Quality Unit lacked the authority to review batch production records from its contract manufacturer, hindering full investigation of potential errors. The Quality Unit also failed to follow established written procedures, particularly regarding the timely closure of complaints. Complaint investigations were deemed inadequate, with instances where necessary follow-up with the contract manufacturer was not initiated despite sufficient information. Crucially, the firm failed to identify and report Adverse Drug Events to the FDA for product-related injuries, and it lacked a dedicated written recall procedure for drug products, relying on a medical device procedure instead. Discussions with management also highlighted unupdated written procedures for drug products, inconsistent documentation practices, and a Quality Agreement missing assignments for adverse drug event reporting, retain sample retention, supplier auditing, and stability testing. The firm's registration status as a drug repackager was also noted as inaccurate for its operations. Veridian Healthcare's management acknowledged the findings and committed to a written response to the FDA within 15 business days, outlining plans to correct all identified issues within six months. This includes updating all relevant procedures for drug products, improving complaint investigation processes, performing an audit of their contract manufacturer, and revising the Quality Agreement to clearly define responsibilities.