FDA EIR - Quality Chemical Laboratories - July 27, 2017

An FDA cGMP inspection of Quality Chemical Laboratories, LLC, a contract testing laboratory and API manufacturer in Wilmington, NC, was conducted from July 24-27, 2017. The inspection, carried out under current Good Manufacturing Practices for drug manufacturing, identified significant deficiencies in the firm's quality and production control systems. Two primary observations were issued on Form FDA-483. First, the quality control unit's responsibilities and procedures were not consistently followed, including instances where audit findings were initially misdocumented as having no issues and quality assurance management failed to identify these discrepancies. Second, written production and process control procedures were not documented contemporaneously. Specifically, the usage of major laboratory instruments, such as HPLCs and GCs, was often recorded days or weeks after actual use, hindering traceability. Further discussions with management highlighted additional concerns, including the commingling of items in stability storage, insufficient data backup for certain instruments not connected to the firm's central server, and a delay in closing numerous laboratory investigations. These issues collectively indicate a need for enhanced adherence to regulatory requirements and improved quality management system oversight to ensure the integrity and reliability of laboratory operations and product manufacturing.