FDA EIR - Dental Technologies Inc. - June 29, 2017

An FDA surveillance inspection of Dental Technologies, Inc. in Lincolnwood, IL, was conducted from June 20 to June 29, 2017. The firm manufactures prescription and over-the-counter drug products, alongside medical devices. The inspection utilized the drug manufacturing inspection compliance program and focused on Quality and Laboratory Systems under a Good Manufacturing Practice (GMP) framework. While no formal FDA-483 was issued, six discussion points highlighted areas for improvement. Concerns included recurring microbial alerts in the Deionized Water system, despite the firm's strict internal standards, which prompted a thorough cleaning and increased monitoring. Process validation issues were identified for a topical analgesic, leading to container/closure failures, though corrective actions were already in progress company-wide. Facility operational space was noted as inadequate, with cramped stability storage and a cluttered pre-weigh area. Cleaning procedures for a fluoride toothpaste were found deficient after product contamination by a frayed processing component, leading to a commitment for mandatory component changes and new procedures. Complaint investigations often lacked identified root causes, and initial computer system validation lacked unique user identifiers, which the firm rectified during the inspection. Management committed to addressing these observations, enhancing compliance and product integrity.