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# Cook Medical Gets Warning Letter Close-out
- URL: https://www.fdaweb.com/cook-medical-gets-warning-letter-close-out/
- Published: 2018-09-11T12:00:00.000Z
- Updated: 2026-09-15T00:31:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142325

Cook Medical has received an FDA close-out letter resolving a 2014 Warning Letter for processes related to the company’s quality system at its manufacturing facility in Bloomington, IN. The [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm419624.htm?ref=fdaweb.com) from the Detroit District Office said that violations noted in the inspection included:

- failing to validate, with a high degree of assurance, and approve according to established procedures a manufacturing process that cannot be fully verified by subsequent inspection and testing to ensure the process will continue to meet specifications;
- failing to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure the specified requirements continue to be met;
- failing to establish and maintain procedures for implementing corrective and preventive action;
- failing to establish and maintain procedures for accepting incoming products to ensure conformance with specified requirements;
- failing to establish and maintain procedures to control product that does not conform to specified requirements;
- failing to establish and maintain written sampling plans based on valid statistical rationale that are adequate for their intended use; and
- failing to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.