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# CGMP Issues in DeChoker Inspection
- URL: https://www.fdaweb.com/cgmp-issues-in-dechoker-inspection/
- Published: 2021-06-01T12:00:00.000Z
- Updated: 2026-09-14T17:01:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149434

A 2/17-2/26 FDA inspection at the DeChoker medical device operation in Wheat Ridge, CO, determined that the firm manufactures the DeChoker tracheobronchial suction device. A 5/10 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dechoker-llc-614629-05102021?ref=fdaweb.com) says the device is adulterated because it does not conform to the current good manufacturing practice requirements of the Quality System regulation. Specific violations were: 

- failing to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to established procedure;
- failing to establish and maintain adequate procedures to control the design of the device to ensure that specified design requirements are met;
- failing to establish and maintain adequate procedures for implementing corrective and preventive action;
- failing to establish and maintain adequate procedures for acceptance activities, including inspections, tests, or other verification activities; and
- failing to establish and maintain adequate procedures for rework, including retesting and reevaluation of the nonconforming product after the rework, to ensure that the product meets its current approved specifications.

The letter says the firm’s responses to the inspection observations were inadequate. FDA told DeChoker to take prompt action to correct the violations and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the steps, and a timetable for completing the work.

FDA also requested a regulatory teleconference to discuss the violations and the company’s ongoing corrective actions.