FDA WARNING_LETTER - Dental Technologies, Inc. - April 12, 2011

The FDA issued a Warning Letter to Dental Technologies, Inc. following an inspection from March 16 to April 12, 2011, identifying significant Current Good Manufacturing Practice (CGMP) violations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering their drug products adulterated. Additionally, the firm manufactures unapproved new prescription drugs, violating Sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of Identity Testing:** Failure to perform specific identity tests for Glycerin USP (e.g., Diethylene Glycol and Ethylene Glycol) and establish supplier analysis reliability (21 CFR § 211.84(d)(2)). The firm's response was inadequate as it lacked actual test results. 2. **Inadequate Investigations:** Failure to thoroughly investigate out-of-specification results, such as microbial contamination (Pseudomonas aeruginosa) in water samples, and extend investigations to other affected batches (21 CFR § 211.192). The firm's response lacked details on sample testing and corrective actions for the water system. 3. **Failure to Follow Complaint Procedures:** Inadequate investigation of consumer complaints, specifically patient illness complaints for nausea and vomiting related to fluoride products, without evaluating manufacturing processes, raw materials, or packaging, or extending investigations