MTI Warned Over Complaint Handling Problems and Recall Reporting
MTI Precision Products received an FDA warning letter for complaint handling, recall missteps and other quality issues.
The Lakewood, N.J., dental products maker failed to ensure all complaints are evaluated for reportability, according to the June 6 letter posted online. For example, a complaint that a high-speed handpiece was in pieces in a patient’s mouth was not evaluated after the company found there was no injury.
Additionally, not all complaints — such as customer complaints handled as service repairs — are reviewed and evaluated by company management, the warning letter notes. An invoice documented two nose cones returned for a possible manufacturing defect. MTI treated the issue as a repair instead of reviewing and evaluating it as a complaint, the letter says. It followed an April 17-30 inspection by the FDA’s New Jersey District Office.
MTI also did not submit a written report to the FDA for a May 2012 recall of TM 20 low-speed dental handpieces manufactured between March 1 and May 7, 2012. The company sent voluntary recall letters to customers requesting they return the devices after a customer complaint about a sharp edge on the nose portion of the device.
The company’s corrective action was to rework existing stock, but it did not document those activities or its determination of any adverse effects, the FDA investigator found. Meanwhile, MTI’s design controls procedure does not require validation or verification of design changes before their implementation.
Supplier control also drew the FDA’s attention as MTI did not evaluate and select potential suppliers based on their ability to meet specified requirements.
Additional citations note that MTI’s quarantine procedure and dental products product conformance testing protocol don’t address the evaluation and documentation of a nonconformance. They also don’t address how to determine the need for an investigation. Further, MTI failed to implement its procedures for quality audits, GMP training and maintaining device history records, and it did not implement CAPAs.
MTI did not respond to a request for comment by press time.
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