Beckman Coulter receives FDA warning letter

The warning letter identifies the DxI 9000 Access Immunoassay analyzer instrument system and its assays as the items deemed "adulterated" due to compliance shortcomings. 

During the FDA's inspection of the facility in November and December 2023, observations were categorized into four groups. The initial group pertains to Beckman’s failure to sufficiently establish and maintain procedures for risk analysis. Specifically, the FDA highlighted instances where the Severity Rating was inaccurately chosen for numerous assays’ false result failure modes, emphasizing the increased risk of hepatitis B virus transmission due to false negative results and the potential for mistreatment stemming from false positive results in certain tests.

The second group of observations relates to the inadequacy of procedures for corrective and preventative actions. The FDA criticized procedures for analyzing quality data to identify existing and potential causes of nonconforming products or other quality issues.

In the remaining two groups of observations, the FDA addressed the absence of adequate procedures to control products that do not meet specified requirements and for design changes. The agency noted deficiencies in the procedure triggered when identifying non-conforming products in the manufacturing area, citing a lack of detailed guidelines to ensure the proper evaluation, investigation, segregation, and disposition of components.