FDA WARNING_LETTER - Dental Technologies Inc. - January 20, 2021

The FDA inspected Dental Technologies Inc. (FEI 1413475) from December 7, 2020, to January 20, 2021, identifying significant violations of CGMP for finished pharmaceuticals (21 CFR parts 210 and 211) and Quality System (QS) regulations for medical devices (21 CFR part 820). This resulted in drug products being deemed adulterated under section 501(a)(2)(B) of the FD&C Act, with Paroex 0.12% chlorhexidine oral rinse specifically cited as adulterated under section 501(a)(2)(A) due to insanitary conditions and potential contamination. G•U•M® HYDRAL™ OTC products were also deemed adulterated devices under section 501(h) due to non-conformity with QS regulations.

Key drug CGMP violations include: 1. **Inadequate investigations into discrepancies (21 CFR 211.192):** The firm failed to thoroughly investigate failing microbiological results, particularly for Paroex 0.12% chlorhexidine oral rinse, which was contaminated with *Burkholderia cepacia complex* (BCC). The investigation inadequately addressed root causes, cleaning deficiencies, and failed to implement systemic CAPA. An invalidated *Pseudomonas aeruginosa* result for AlphaC