PRIME MATTER LABS WEST LLC – FDA 483, Aug 25, 2022

PRIME MATTER LABS WEST LLC in Torrance, CA, a manufacturer, was cited for three significant issues during an FDA inspection. These included an inadequate investigation into microbial contamination of an SPF 50 product, a failure to calibrate a critical thermometer used in drug batch production, and a deficiency in validating supplier certificates of analysis for active pharmaceutical ingredients. The findings indicate a lack of thoroughness in quality control and supplier management practices.