# FDA WARNING_LETTER - DRG Instruments GmbH - October 28, 2016

Source: https://www.keypedia.com/records/warning_letter/drg-instruments-gmbh/f83880cb-3137-41a7-a911-c959bb809db4

> FDA WARNING_LETTER for DRG Instruments GmbH on October 28, 2016. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: DRG Instruments GmbH
- Inspection Date: 2016-10-28
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On October 24-28, 2016, an FDA inspection of DRG Instruments GmbH in Marburg, Germany, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820) for their ELISA devices, including 17-alpha-OH Progesterone, Salivary Cortisol, Estradiol, and Salivary Testosterone. The firm's response dated January 16, 2017, was deemed inadequate.

Key violations include:
1.  **Failure to establish and maintain process control procedures (21 CFR 820.70(a))**: Reworked microplates due to QC failures lacked written procedures for antibody storage and solution preparation. No freeze/thaw study was conducted for partially used antibody vials.
2.  **Inadequate corrective and preventive actions (CAPA) (21 CFR 820.100(a))**: CAPA Report No. 2016-16 for Estradiol Salivary ELISA (Lot No. 68K056) failed to identify actions to correct communication failures of manufacturing changes or verify CAPA effectiveness. A documentation change control system was not established.
3.  **Failure to establish training procedures (21 CFR 820.25(b))**: Lack of employee training records for updated procedures and no specified procedures to ensure adequate training for assigned duties

## Related Documents

- [WARNING_LETTER - 2024-11-07](https://www.keypedia.com/records/warning_letter/drg-instruments-gmbh/51bbefc6-dc80-4832-abad-5469bb43fafb)

## Related Officers

- [Director](https://www.keypedia.com/people/alberto-gutierrez/ec16aa77-9dd3-4aff-aae4-1540ea96c5b8)

Company: https://www.keypedia.com/companies/drg-instruments-gmbh/5a8981ef-7bb3-4af6-a73f-01be1234ce51

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