FDA EIR - Wasatch Product Development, LLC - September 12, 2008

An FDA inspection of Wasatch Product Development, LLC, a contract manufacturer of over-the-counter (O-T-C) drugs, was conducted from September 9-12, 2008. This inspection was part of a routine drug manufacturing surveillance program, specifically Compliance Program 7356.002. During the inspection, the firm was found to have relocated to a new unit within the same business park, completing the build-out in June 2008. They installed all new processing equipment, except for one transferred tank. At the time, Wasatch Product Development was primarily manufacturing cosmetics and preparing to resume O-T-C dermatological product manufacturing, having registered with the FDA as a drug establishment on August 24, 2008. The company was in the final stages of implementing a comprehensive Current Good Manufacturing Practice (cGMP) program, with plans to release finished drug batches by the end of 2008. Crucially, the assessment of the new manufacturing facility revealed no deficiencies. Consequently, no FDA Form 483 was issued to the company. This marks a significant improvement from a previous inspection in October 2004, which resulted in 32 cGMP deficiencies related to topical O-T-C drug products. All issues cited during that prior inspection were found to be corrected. The current inspection was classified as "No Action Indicated (NAI)," with a routine reinspection tentatively scheduled for September 2010.