FDA 483 - Cosette Pharmaceuticals, Inc. - February 15, 2018

An FDA inspection of G & W Laboratories, Inc., a drug manufacturer in South Plainfield, NJ, was conducted from February 1 to February 15, 2018, revealing multiple significant deviations from Current Good Manufacturing Practice (CGMP) regulations. The Form FDA 483 highlighted critical failures across several areas. The company's Quality Control Unit neglected to qualify and routinely audit suppliers and computerized GxP systems, and failed to establish required quality agreements. Complaint handling procedures were inadequate, with numerous product complaints not being timely initiated, investigated, or closed, and no response letters issued to complainants. Investigations into Out-of-Specification results frequently attributed issues to instrument error without implementing proper corrective actions to prevent recurrence. Furthermore, material handling was deficient, allowing open sampling in the warehouse and unverified material statuses. A critical observation noted that approximately 600 batches of drug products were manufactured using equipment with known intermittent malfunctions during crucial mixing stages, directly compromising validated processes. G & W Laboratories must undertake comprehensive corrective and preventive actions to address these systemic issues and ensure regulatory compliance and product quality.