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# QS Issues at Circulatory Technology
- URL: https://www.fdaweb.com/qs-issues-at-circulatory-technology/
- Published: 2019-02-14T12:00:00.000Z
- Updated: 2026-09-15T01:04:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143381

An 8/22-9/26/18 FDA inspection at Circulatory Technology, Oyster Bay, NY, found Quality System Regulation violations in the firm’s work as a specification developer of the Better Bladder and Bigger Better Bladder medical devices. A just-released 1/28 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm631121.htm?ref=fdaweb.com) says the violations were: 

- failing to perform and document revalidation activities when changes or process deviations occur in the manufacturing operations;
- failing to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met;
- failing to evaluate complaints to determine whether the complaint represents an even that is required to be reported to FDA under the Medical Device Reporting regulation; and
- failing to document all required corrective and preventive actions.

FDA says the company either did not respond to a specific inspection observation or its responses were inadequate. Circulatory Technology was told to take prompt action to correct the violations. It was told to submit a list of steps taken to correct the violations and prevent their recurrence, with documentation for each correction and a timetable for completion. The agency also asked that the company submit on a defined schedule certification by an outside expert consultant that he or she has audited the company’s manufacturing and quality assurance systems relative to Quality System Regulation requirements.