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# QS Violations Found in Grams Medical Inspection
- URL: https://www.fdaweb.com/qs-violations-found-in-grams-medical-inspection/
- Published: 2016-05-03T12:00:00.000Z
- Updated: 2026-09-14T20:59:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135552

A 9/14-25/15 FDA inspection at Grams Medical Products, Costa Mesa, CA, found Quality System Regulation violations in the firm’s manufacturing of the Grams Aspirator S-300\. A just-released 3/17 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm496462.htm?ref=fdaweb.com) from the agency’s Los Angeles District Office says that violations listed on an FDA-483 included: 

- failing to adequately validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures;
- failing to adequately maintain a device master record;
- failing to establish procedures for device history records;
- failing to have management with executive responsibility review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency;
- failing to perform quality audits at defined intervals and at sufficient frequency to determine whether the quality system activities and results comply with quality system procedures; and
- failing to develop, maintain, and implement written Medical Device Reporting procedures.

 Grams was told to take prompt steps to correct the violations and to respond with a list of specific actions taken, documentation of each action, and a timetable for completion.