FDA 483 - Neos Therapeutics, LP - August 25, 2023

Neos Therapeutics, LP, a drug manufacturer in Grand Prairie, TX, was cited for two significant observations during an FDA inspection. The firm failed to appropriately validate component supplier test results and update product specifications according to a new USP monograph for Polyethylene Glycol. Additionally, the company did not follow established laboratory control mechanisms, specifically regarding the accountability of raw laboratory data sheets used for dissolution testing.