FDA EIR - Chartwell Pharmaceuticals LLC - September 26, 2018

An FDA inspection of Chartwell Pharmaceuticals, LLC, located in Congers, NY, was conducted from September 12 to September 26, 2018. The inspection, performed under the Drug Manufacturing Inspection compliance program, focused on the company's Quality System, Facilities and Equipment, and Laboratory Control System. The inspection revealed several issues related to Current Good Manufacturing Practices. The main violations included a lack of established written procedures for equipment cleaning and maintenance, specifically failing to conduct protocol-driven cleaning validation studies for manufacturing equipment. Additionally, the firm lacked complete temperature mapping studies for its Finished Goods/Raw Material Warehouse, indicating insufficient procedures for drug product warehousing. There were also no written procedures for performing laboratory instrument audit trail reviews, which compromised electronic record reliability and data integrity. Lastly, the facility's raw material and finished goods warehouse had inadequate space, leading to potential mix-ups and cross-contamination. Company management acknowledged these observations and committed to implementing corrective actions, promising to submit a formal response to the FDA within 15 business days following the inspection.