FDA 483 - Matrixx Initiatives Inc - May 28, 2009

On May 26 and May 28, 2009, the FDA inspected Matrixx Initiatives Inc., a drug manufacturer located at 8515 E Anderson Dr, Scottsdale, AZ 85255-5461. The inspection was conducted by Investigator Timothy T Kapsala, and the report was issued to Tim L. Clarot, Vice President R&D and Product Quality.

The sole observation noted was that serious adverse events for a non-prescription drug used in the United States had not been reported to the Secretary. Specifically, the firm did not classify and report anosmia (loss of smell) or loss of taste as serious adverse events, and consequently, these complaints were not reported to the Food and Drug Administration's MedWatch reporting system. Three specific complaints, AE09-000723, AE09-000736, and AE09-000886, were identified as not having been reported.