FDA EIR - Dental Technologies Inc. - March 12, 2019

Dental Technologies Inc., a manufacturer of non-sterile oral pharmaceutical products and medical devices, was subject to an FDA drug surveillance inspection from January 24 to March 12, 2019. Conducted under Compliance Program 7356.002, the inspection primarily focused on the company's Quality, Production, and Laboratory Controls Systems for drug manufacturing. The main violation, detailed in a one-point FDA-483, highlighted inadequate laboratory testing of drug products for objectionable microorganisms. The firm utilized an alternative microbiology method that did not align with current USP chapters <61> and <62>. Specific issues included deficient validation studies, such as incorrect microbial incubation times, failure to verify sample pH, and insufficient sample weights. Additionally, the company's routine microbiology test procedure lacked the USP-required duplicate plating. This observation marked a recurring issue for the company, having been cited in previous inspections and a 2011 Warning Letter. Management initiated immediate corrections during the inspection, successfully revising and implementing their change control procedure. They also began addressing ambiguities in their Out-Of-Specification procedure. Dental Technologies Inc. committed to submitting a written response to the FDA within 30 days outlining their detailed corrective and preventive actions. The company's registration for both drug and medical device manufacturing was verified.