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# Latest FDA Warning Letter
- URL: https://www.fdaweb.com/latest-fda-warning-letter/
- Published: 2019-12-03T12:00:00.000Z
- Updated: 2026-09-14T15:55:13.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145640

FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below:

**American Contract Systems**, Houston, TX (11/9): FDA inspected the firm in September and found Quality System Regulation violations with various surgical trays/kits for hospital use. For example, American Contract failed to adequately validate with a high degree of assurance a process whose results cannot be fully verified by subsequent inspection and test. It also failed 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. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/american-contract-systems-inc-595573-11092019?ref=fdaweb.com).