FDA EIR - Fresenius Kabi USA LLC - December 03, 2018

The FDA conducted an inspection of Fresenius Kabi USA LLC in Melrose Park, IL, from November 29 to December 3, 2018. The inspection, carried out under Compliance Program C.P. 7382.845 for Medical Device Manufacturers, focused on the company's processes for Corrective and Preventive Actions (CAPA), production records, and Medical Device Reporting (MDR) related to medical device and combination products. The company is a registered medical device manufacturer and produces drug products such as the Glucagon vial with a syringe kit.

Significantly, the FDA did not issue any Form FDA-483 Inspectional Observations, indicating no formal violations were identified during this inspection. However, a primary discussion point with management at the inspection's conclusion involved the firm's device registration and listing updates. While no specific regulatory actions were formally mandated, management was reminded of its responsibilities to adhere to the Food, Drug, and Cosmetic Act to prevent potential consequences for non-compliance. The company noted it had no device recalls in the prior two years and that device manufacturing, currently paused, could resume as needed.