FDA 483 - Huvepharma, Inc. - March 09, 2022

Huvepharma, Inc. in Peachtree City, GA, was inspected from February 22 to March 9, 2022. The inspection revealed that the sponsor's compliance statement asserting studies were conducted in accordance with Good Laboratory Practice (GLP) could not be substantiated. This was primarily due to a lack of documentation regarding the adequacy of the contracted testing facility, the procedures of the quality assurance firm, and medical follow-up for reported adverse events.