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# QS Issues in Beckman Coulter Inspection
- URL: https://www.fdaweb.com/qs-issues-in-beckman-coulter-inspection/
- Published: 2024-04-02T12:00:00.000Z
- Updated: 2026-09-14T14:27:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156682

An 11/1-12/11/2023 FDA inspection at the Beckman Coulter facility in Chaska, MN, found Quality System Regulation violations in the firm’s manufacturing of the DxI 9000 Access Immunoassay analyzer instrument system and assays. A 3/15 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/beckman-coulter-inc-678042-03152024?ref=fdaweb.com) says specific violations were:

- failure to adequately establish and maintain procedures for risk analysis;
- failure to adequately establish procedures for corrective and preventive action;
- failure to adequately establish procedures to control product that does not conform to specified requirements; and
- failure to adequately establish procedures for design changes.

The letter says the agency was unable to determine the adequacy of the firm’s responses to the inspection observations. Beckman Coulter was told to take prompt action to address violations and respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.