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# QS Violations at Germany’s DRG Instruments
- URL: https://www.fdaweb.com/qs-violations-at-germanys-drg-instruments/
- Published: 2017-10-24T12:00:00.000Z
- Updated: 2026-09-14T22:57:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139948

A 10/24-10/28/16 FDA inspection at DRG Instruments, Marburg, Germany, found Quality System Regulation violations in the firm’s manufacturing of 17-alpha-OH Progesterone ELISA, Salivary Cortisol ELISA, Estradiol ELISA, Salivary Testosterone ELISA, and Testosterone ELISA. Specific violations noted in a 9/19 Warning Letter were: 

- · failing to establish and maintain process control procedures describing any process controls necessary to ensure conformance to specifications where deviations from device specifications could occur due to the manufacturing process;
- failing to **(1)** identify the actions needed to correct and prevent recurrence of nonconforming product and other quality problems; **(2)** verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device; **(3)** implement and record changes in methods and procedures needed to correct and prevent identified quality problems; and **(4)** ensure that information related to quality problems or non-conforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and
- failing to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.

The agency says the firm’s responses to the inspection observations were inadequate. It also says the inspection found that DRG failed to submit a report of correction or removal for the Estradiol Salivary ELISA and found that the company does not have an approved PMA or IDE in effect for the Salivary Cortisol ELISA and did not notify FDA of its intent to introduce that device into commercial distribution.

Given the serious nature of the violations, FDA says, it is taking steps to refuse entry of the devices into the U.S. through detention without physical examination until the violations are corrected. DRG was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of each step and a timetable for completion.