FDA EIR - Tusker Medical, Inc. - October 25, 2019

Tusker Medical, Inc. underwent an FDA Premarket Approval (PMA) pre-approval inspection from October 21-25, 2019, in Menlo Park, CA. This inspection, conducted under the Medical Device User Fee Amendments (MDUFA) framework, assessed the firm's compliance with Good Manufacturing Practices (GMP) for its TULA System, a combination product intended for treating otitis media. The review covered Management Controls, Corrective and Preventive Action (CAPA), Design Controls, Production & Process Controls, and ancillary systems.

Crucially, no Form FDA 483, which details significant inspectional observations or violations, was issued to Tusker Medical, Inc. at the conclusion of this inspection. However, a specific discussion item was noted regarding the firm's receiving inspection sample size. It was observed that one raw material lot had been sampled using a smaller size than required by the company's own written procedures.

In immediate response, Tusker Medical, Inc. initiated a Nonconformance Report (NCR). The company proceeded to conduct additional sampling of the remaining raw material to meet the correct sample size and reviewed subsequent receiving inspections, confirming no other discrepancies. This proactive resolution addressed the observation without necessitating formal regulatory action, indicating the firm's general adherence to quality system requirements for their TULA System.