FDA WARNING_LETTER - Dental-Kosmetik GmbH & Co. KG - July 19, 2019

On January 16, 2020, the FDA issued a Warning Letter to Dental-Kosmetik GmbH & Co. following an inspection from July 15-19, 2019, at their Dresden, Germany facility. The inspection revealed significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated under the FD&C Act. The firm's August 2, 2019, response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Failure to establish written procedures for production and process control (21 CFR 211.100(a))**: The firm failed to adequately validate manufacturing processes, lacking process performance qualification studies and ongoing monitoring. Their process validation involved testing only the first batch, and significant deviations from batch instructions were made to achieve passing results. The "Nonconformity Management" procedure was inadequate, allowing repeat testing without root cause investigation. Additionally, the firm's (b)(4) system, used in drug products and for cleaning, was not adequately designed, controlled, maintained, or monitored to ensure it met USP monograph specifications and microbial limits, lacking validation and appropriate testing (e.g., conductivity).

2. **Inadequate stability testing program (21 CFR 211.166(a))**: The firm lacked sufficient long-term stability data to support a three