Matrixx Initiatives, Inc. – FDA 483, May 25, 2005

An FDA inspection of Matrixx Initiatives, Inc., also known as Zicam LLC, conducted from May 25-27, 2005, identified a significant issue related to the company"s complaint handling procedures. As an own-label drug distributor, Matrixx"s quality system, particularly its complaint records and follow-up, was the focus, prompted by numerous consumer and Medwatch complaints concerning anosmia (loss of smell/taste) linked to their zinc-containing nasal products. The inspection resulted in a single observation on an FDA Form 483: a failure to consistently adhere to written procedures for managing complaints. Specifically, for product safety complaints, a required field on the "Drug Product Complaint" form (Form A)—designating the "name of decision maker and date" when an investigation was not deemed necessary—was frequently left blank on forms from February, March, and April 2005. In response, Matrixx Initiatives" management committed to a thorough review and revision of their complaint handling Standard Operating Procedure (SOP QA-001) and the complaint form to enhance clarity and consistency. They also pledged to implement retraining for staff involved in complaint processing, including their contract complaint organization. The company assured the FDA of a forthcoming written response addressing these corrective actions.