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# QS Violations Found at American Contract Systems
- URL: https://www.fdaweb.com/qs-violations-found-at-american-contract-systems/
- Published: 2019-12-03T12:00:00.000Z
- Updated: 2026-09-14T15:55:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145626

A 9/9-10/4 FDA inspection at the American Contract Systems medical device operations in Houston, TX, found Quality System Regulation violations in the firm’s work as a medical device manufacturer and contract sterilizer of various surgical trays/kits for hospital use. A just-released 11/9 Warning Letter lists specific violations as: 

- failing to adequately validate with a high degree of assurance a process whose results cannot be fully verified by subsequent inspection and test;
- failing to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specific requirements continue to be met;
- failing to document the review and evaluation of a process performed in response to changes or process deviations;
- failing to adequately validate computer software as part of production for its intended use according to an established protocol; and
- failing to adequately maintain device master records.

The letter says the agency did not receive the firm’s response to the inspection observations to determine if corrections and/or corrective actions had been implemented to address any of the violations.

American Contract 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, including documentation of the corrections and/or corrective actions and a timetable for completion of the steps.