FDA EIR - Fresenius Kabi USA LLC - December 11, 2013

The FDA conducted an inspection of Fresenius Kabi USA LLC's Melrose Park, IL facility from September 25 to December 11, 2013. This inspection focused on human sterile injectable drug product manufacturing and one Class II medical device, utilizing compliance programs for drug manufacturing, sterile drug processes, and medical devices. The inspection revealed three primary observations on Form FDA-483.

Key issues included the company's approval of a contract manufacturer despite uncorrected "critical observations" from an audit, which subsequently led to product recalls. Deficiencies in microbial controls within the ISO 5 aseptic filling areas were also noted, specifically concerning the use of conveyor tape that proved resistant to established disinfectants for several tested organisms. Furthermore, the firm lacked adequate smoke study data to support interventions involving the removal of fallen vials in aseptic filling lines, raising concerns about maintaining a sterile environment.

The inspection also highlighted delays in completing annual product quality reviews and a notable increase in Field Alert Reports, detailing issues such as missing lot numbers, unsealed vials, out-of-specification impurities, and product discoloration. Fresenius Kabi USA LLC committed to submitting a written response to the FDA's Chicago District Office within 15 business days, in light of the Agency's warning of potential legal sanctions.