FDA 483 - Quality Chemical Laboratories - July 27, 2017

An FDA inspection of Quality Chemical Laboratories, LLC in Wilmington, NC, a contract testing laboratory and API manufacturer, identified significant deficiencies in their quality control unit and documentation practices. The firm failed to accurately record and follow up on audit findings, and did not document instrument usage in real-time as required by their procedures. These issues indicate a lack of adherence to established quality assurance and production control protocols.