Fresenius Medical Care de Mexico, SA de CV – FDA 483, Dec 4, 2018

Fresenius Medical Care de Mexico, a sterile drug manufacturer in Zapopan, Jalisco, Mexico, was cited with four observations during an FDA inspection. The firm failed to adequately investigate batch failures and numerous product complaints, did not maintain proper records for equipment calibration and qualification, and had deficiencies in visual inspection procedures and retain sample collection. These issues indicate significant concerns regarding quality control and adherence to manufacturing specifications.