FDA EIR - Wasatch Product Development, LLC - March 04, 2016

Wasatch Product Development, LLC, an OTC drug, cosmetic, and dietary supplement contract manufacturer, underwent a comprehensive FDA cGMP inspection from February 29 to March 4, 2016. The inspection, conducted under Compliance Program 7356.002, identified two main observations on Form FDA 483.

The primary violation concerned the Quality Control Unit's failure to establish and fully follow written procedures (21 CFR 211.22(d)). This included an inadequate Annual Product Review procedure that omitted critical quality data like rejected batches and stability studies. Additionally, there were discrepancies in deviation reporting, lack of QA review for annual reports, and insufficient assessment of product quality impact in change control processes. Investigations into out-of-specification results lacked thoroughness and supporting data, particularly regarding menthol assay. The firm's content uniformity sampling plan did not align with USP <905> guidelines, and the cleaning and sanitizing validation report lacked essential details regarding its applicability to OTC products and specific cleaning parameters.

The second observation noted that actual and theoretical yield percentages were not consistently determined at the conclusion of each packaging phase. Furthermore, the inspection uncovered the manufacturing and interstate distribution of two unapproved new drugs: a progesterone topical cream and saline nasal drops, which did not comply with OTC monograph requirements. Wasatch committed to ceasing production of these unapproved products. Issues were also noted with a contract testing laboratory regarding the absence of a Quality Unit, insufficient record review, and lack of GMP training.

Management, including President Kevin L. Casey, acknowledged the observations and promised written corrections within 15 business days. The firm also committed to conducting a follow-up audit for its contract laboratory.