FDA 483 - FMKLABS - December 31, 2024

FMKLABS, a drug manufacturer in Corona, CA, was inspected by the FDA and received a Form 483 with four observations. The inspection revealed significant issues including a failure to investigate out-of-specification results and cleaning validation failures, inadequate process validation and in-process controls, unverified testing methods, and an unvalidated water system. These deficiencies indicate a lack of robust quality control and manufacturing processes.