FDA EIR - Element Materials Technology Oakland-Concord - December 21, 2018

A routine FDA inspection of Microbiology & Quality Associates LLC, a contract laboratory in Concord, CA, was conducted from December 17-21, 2018. This inspection, performed under the FDA’s Pharmaceutical Division IV workplan for drug manufacturing, identified three significant compliance issues documented on an FDA Form 483. First, the firm's quality control unit did not consistently follow its established procedures for sample transportation. Temperature-sensitive samples were frequently transported outside required cold temperature ranges, and the firm failed to investigate these critical excursions, potentially compromising the integrity of the samples. Second, deficiencies were found in employee training and qualification. A Facility Specialist certified a Biological Safety Cabinet (BSC), crucial for sterility testing, without possessing the necessary training or qualifications as outlined in the firm's own written protocols. Additionally, the smoke test performed for this BSC certification lacked dynamic operational conditions, failing to adequately assess its performance under use. Third, the calibration of critical laboratory equipment was inadequate. The firm neglected to calibrate the pressure gauges on its seven Biological Safety Cabinets at appropriate intervals, contrary to its documented program. This oversight raises concerns about the accuracy and reliability of environmental controls within these cabinets. Management acknowledged these observations and committed to providing a detailed written response to the FDA within 15 business days. Immediate corrective actions initiated during the inspection included revising sample transport protocols to ensure proper segregation of samples and beginning the calibration of BSC pressure gauges. The FDA conveyed that failure to promptly and adequately address these issues could lead to further regulatory enforcement actions.