Fresenius Kabi USA LLCSeptember 1, 2015

FDA 483 - Fresenius Kabi USA LLC - September 01, 2015

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Record Details

Fresenius Kabi USA LLC in Melrose Park, IL, was inspected from August 17 to September 1, 2015. The inspection revealed a significant issue with the firm's packaging and labeling operations, specifically concerning the lack of independent verification for visual inspections of cut labels. This indicates a potential risk to product quality due to inadequate quality control procedures.

Company: Fresenius Kabi USA LLC
Inspection Date: September 1, 2015
Product Type: Drugs
Office: Chicago District Office
Person: Christopher D. Leach (Compliance Officer at FDA)

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