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# Multiple Violations in Qiagen U.S. Facility
- URL: https://www.fdaweb.com/multiple-violations-in-qiagen-u-s-facility/
- Published: 2016-05-24T12:00:00.000Z
- Updated: 2026-09-14T21:05:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135750

A 1/19-2/5 FDA inspection at the Germantown, MD, manufacturing facility operated by Germany’s Qiagen found multiple violations in the firm’s manufacturing of the QuantiFERON-TB Gold test device, according to a 5/16 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm501292.htm?ref=fdaweb.com). Violations listed on an FDA-483 included: 

- procedures for corrective and preventive actions were not adequately established to ensure that the actions are effective;
- requirements that must be met by suppliers and contractors were not adequately established;
- procedures for design change were not adequately established;
- procedures for design output were not adequately established;
- complaints involving the possible failure of a device to meet any of its specifications were not evaluated and investigated where necessary;
- sampling plans are not written and based on valid statistical rationale;
- a report was not submitted to FDA no later than 30 days after the firm received or otherwise became aware of information, from any source, that reasonably suggested that a device that the firm markets had malfunctioned and that the device or a similar one would be likely to cause or contribute to a death or serious injury;
- failing to adequately develop, maintain, and implement written medical device reporting procedures; and
- failing to submit a written report to FDA of a correction or removal of a device initiated to reduce a risk to health posed by the device, or to remedy a violation of the Federal Food, Drug, and Cosmetic Act caused by the device.

The company was told to take prompt action to correct the violations and to respond with a list of specific steps taken, documentation of each step, and a timetable for completion.