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# QS Violations in Kelynian Global Inspection
- URL: https://www.fdaweb.com/qs-violations-in-kelynian-global-inspection/
- Published: 2017-10-17T12:00:00.000Z
- Updated: 2026-09-14T22:56:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139886

A 5/10-5/30 FDA inspection at Kelynian Global, Canton, CT, found Quality System Regulation violations in the firm’s manufacturing of patient-specific cranial implants and maxillofacial implants, according to a 10/5 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580281.htm?ref=fdaweb.com). Specific violations listed on an FDA-483 were: 

- failing to establish and maintain design change procedures;
- failing to evaluate complaints to determine whether they represent an event that is required to be reported to FDA;
- failing to demonstrate that the device was manufactured in accordance with the device master record;
- failing to validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures;
- failing to establish procedures for acceptance of incoming product;
- failing to have management with executive responsibility review the suitability and effectiveness of the quality system; and
- · failing to establish corrective and preventive actions procedures.

The firm’s responses to the inspection observations were not adequate, FDA says. The agency says the inspection also determined that the firm’s customized cranial/craniofacial implants are adulterated because Kelynian does not have an approved PMA or IDE in effect. And, it says, the implants are misbranded because FDA was not provided a notice or other information about modification to the device.

Kelynian was told to take prompt action to correct the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of the corrections and a timetable for completion.