FDA 483 - Comar Inc. - April 18, 2024

A contract manufacturing facility in Buena, NJ, underwent an FDA inspection from April 15-18, 2024. The inspection, conducted under the Federal Food, Drug, and Cosmetic Act, revealed several critical deficiencies in the company's quality system. Key observations included inadequate Corrective and Preventive Action (CAPA) procedures; specifically, multiple CAPAs lacked thorough root cause analysis, complete corrective actions, or documented verification of effectiveness, impacting issues like out-of-specification measurements and customer complaints. The facility also failed to establish adequate process control procedures, evident by work instructions that did not mandate re-inspections for critical dimension failures, leading to repeated testing until passing results were achieved without proper investigation. Additionally, environmental controls in two cleanrooms were insufficient, with numerous incidents of particulate counts exceeding action limits that lacked documented investigations or corrective actions. Finally, training procedures were found to be inadequate, as a Team Lead responsible for critical manufacturing processes lacked documented training on essential procedures. To address these findings, the firm is required to promptly develop and implement comprehensive corrective actions, ensuring all identified deficiencies are thoroughly investigated, effectively remedied, and verified for sustained compliance with quality system requirements.