FDA WARNING_LETTER - DRG Instruments GmbH - October 28, 2016

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