FDA EIR - Fresenius Kabi USA, LLC - February 01, 2017

An FDA pre-approval inspection of Fresenius Kabi USA, LLC, located in Grand Island, NY, was conducted from January 26 to February 1, 2017. The inspection, carried out under Compliance Program Guidance Manuals for Pre-Approval and Sterile Drug Process Inspections and within the regulatory framework of cGMP under 21 CFR Part 211 and the Federal Food, Drug, and Cosmetic Act, evaluated the firm's compliance for sterile human drug products. Emphasis was placed on a prior-approval supplement for Magnesium Sulfate Injection and follow-up to corrective actions from a previous inspection.

The current inspection resulted in a 4-item FDA 483, citing deficiencies related to media fill qualifications, use of uncontrolled records for visual inspections during media fills, undocumented deviations in media fill batch records and cleaning verification studies, and inadequate documentation of deviations during qualification studies for new manufacturing lines. A prior inspection in 2016 also identified significant issues, including inadequate review of laboratory test records, insufficient investigation of discrepancies, failures in preventing vial damage and contamination, and deficiencies in operator training and microbiological sampling plans.

Additionally, the firm reported 14 Field Alerts and two product recalls, one for incorrect labeling of Cisatracurium Besylate Injection and another for an impurity exceeding specifications in Midazolam Injection, USP. Fresenius Kabi management committed to implementing voluntary corrective and preventive actions. The FDA indicated that failure to address these observations could lead to further regulatory action. A recommendation of Voluntary Action Indicated and approval for NDA 019316/S25 was issued.