Beckman Coulter Inc. – FDA EIR, Oct 30, 2019

A for-cause, follow-up inspection of Beckman Coulter, Inc. (BCI) at its Brea, California corporate office was conducted by the FDA from October 29-30, 2019. The inspection focused on several Class I medical device product recalls involving flow cytometers and cellular analysis systems. The primary issue identified was that BCI had incorrectly listed the Brea facility as the recalling firm on numerous 806 notifications submitted to the U.S. FDA. The actual entity responsible for developing and implementing the recall strategies, performing root cause analyses, and executing corrective actions was BCI's Miami, Florida, facility.

Operating under medical device manufacturing regulations, the FDA investigator clarified that the site originating the recall strategy must be identified as the recalling firm. Although no formal FDA-483 observations were issued, Ms. Noreen Galvin, BCI's Senior Vice President of Quality Assurance and Regulatory Affairs, verbally committed to ensuring all company sites would be informed of the correct reporting procedure. As a voluntary corrective action, the Brea facility promptly coordinated with the Miami facility, which then officially notified the FDA of the corrected recalling entity for the affected products, thereby rectifying the reporting discrepancy.