FDA 483 - Fresenius Kabi USA, LLC - February 04, 2016

Fresenius Kabi USA, LLC, a sterile drug product manufacturer in Grand Island, NY, received an FDA Form 483 citing significant deficiencies. Observations included failures in the quality control unit's review of production records before batch release, inadequate investigation of unexplained discrepancies, and ineffective corrective actions for media fill contamination. Additionally, issues with employee training and the scientific justification for laboratory sampling plans were identified.