Utah OTC Maker Warned for Shoddy Quality Unit, Lack of API Testing

A West Jordan, Utah company that manufactures over-the-counter drug products has been hit with a warning letter for multiple issues at its facility, including a lack of API testing and a failure to put quality unit procedures in place.

SnugZ USA was inspected from Nov. 26-30, 2018 and knocked for releasing numerous OTC drug products without properly testing the identity and strength of their active ingredients. The products, which include the company’s Naawk Aloe Relief Gel + Lidocaine, were also not checked for critical microbial attributes, such as the presence of objectionable microorganisms.

“Without testing each batch, you do not have scientific evidence that all drug product batches conformed to specifications before release,” the agency said.