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# QS Issues Found in Diasol East Inspection
- URL: https://www.fdaweb.com/qs-issues-found-in-diasol-east-inspection/
- Published: 2017-10-03T12:00:00.000Z
- Updated: 2026-09-14T22:53:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139765

A 2/21-3/17 FDA inspection at the Diasol East medical device operation in Watertown, TN, found Quality System Regulation violations in the firm’s manufacturing of liquid and powder dialysate concentrate for hemodialysis. Specific violations listed in the letter were: 

- failing to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications;
- failing to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria;
- failing to establish and maintain procedures to control product that does not conform to specified requirements;
- failing to establish and maintain procedures for implementing corrective and preventive action;
- failing to establish procedures for quality audits; and
- failing to establish and maintain procedures to control all required documents.

The adequacy of the firm’s responses will be determined through a future inspection, the letter says. The firm was told to take prompt action to correct the violations and to respond with a list of the specific steps taken, documentation of each step, and a timetable for completion.