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# QS Issues Found at American Contract Systems
- URL: https://www.fdaweb.com/qs-issues-found-at-american-contract-systems/
- Published: 2018-11-20T12:00:00.000Z
- Updated: 2026-09-15T00:46:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142861

A 9/18-10/2 FDA inspection at American Contract Systems, Zelienople, PA, found Quality System Regulation violations in the firm’s operations as a medical device manufacturer and contract sterilizer of various surgical trays/kits for hospital use. An 11/6 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm625770.htm?ref=fdaweb.com) says specific violations were: 

- 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 specified requirements continue to be met;
- 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 changes to a specification, method, process, or procedure; and
- failing to establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of the regulations.

The letter says the firm’s responses to the inspection observations were inadequate. The company 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, with documentation of each step and a timetable for completion.