FDA 483 - Element Materials Technology Oakland-Concord - December 21, 2018

Microbiology & Quality Associates LLC, a contract laboratory in Concord, CA, received a Form 483 with three observations. The inspection revealed failures in following quality control procedures for sample transport and temperature monitoring, inadequate employee training for critical equipment certification, and a lack of calibration for Biological Safety Cabinet pressure gauges. These issues indicate significant deficiencies in quality system adherence and personnel qualification.