FDA EIR - Wasatch Product Development, LLC - January 18, 2013

Wasatch Product Development, LLC, a contract manufacturer of OTC drugs, cosmetics, and dietary supplements, was inspected by the FDA from January 14-18, 2013. This inspection, conducted under the regulatory framework for drug manufacturing, concluded with a "No Action Indicated" (NAI) classification, and no FDA Form 483 (Inspectional Observations) was issued. A key finding was the successful correction of all ten observations cited in a previous FDA inspection from March 2011. These prior issues included unvalidated manufacturing processes, incomplete batch records, inadequate investigations, insufficient water testing, improper component storage, unvalidated cleaning, uncalibrated equipment, deficient laboratory sampling plans, unfollowed production procedures, and lax labeling controls.

During the current inspection, eight verbal observations were discussed with management, who committed to implementing corrections by the end of February 2013. These included the lack of use of a new raw material sampling suite, insufficient thoroughness in Out-of-Specification (OOS) investigations, expired stability chamber thermometer qualifications, inconsistent inventory status for raw materials, facility disrepair (e.g., chipped floor paint, cracked walls), the absence of a dust collection system in critical areas, an unconducted 2012 Annual Product Review for OTC products, and an incomplete "Packaging Controls" procedure. The company's proactive approach to resolving these matters was noted.