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# QS Violations in Diasol Inspection
- URL: https://www.fdaweb.com/qs-violations-in-diasol-inspection/
- Published: 2017-10-10T12:00:00.000Z
- Updated: 2026-09-14T22:55:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139827

A 5/8-6/15 FDA inspection at the Diasol facility in Phillipsburg, NJ, found Quality System Regulation violations in the firm’s work manufacturing Dryasol liquid acid concentrates and Dryasol powder mixes, and repacking CitriSol Concentrate, liquid Diasol acid concentrates, and liquid and powder sodium bicarbonate. A 9/28 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm579094.htm?ref=fdaweb.com) says that specific violations were: 

- 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, and failing to document acceptance activities to include records of the results;
- failing to establish and maintain procedures to control product that does not conform to specified requirements;
- failing to ensure processes whose results cannot be fully verified by subsequent inspection and test have been adequately validated according to established procedures;
- failing to ensure buildings are of suitable design to perform necessary operations;
- failing to adequately control products that do not conform to specifications; and
- failing to establish and maintain procedures to control all documents for document approval and distribution.

Four of the firm’s responses to the inspection observations were inadequate, FDA says, while two appear to be adequate and will be verified at the next inspection. Diasol was told to take prompt action to correct the violations and to respond with a list of specific steps taken, with documentation for each corrective action and a timetable for completion.