FDA 483 - Bora Pharmaceuticals Inc. - December 19, 2018

Upsher Smith Laboratories, Inc. in Maple Grove, MN, was inspected by the FDA from December 11-19, 2018. The inspection revealed significant deficiencies in laboratory controls, specifically regarding the establishment of scientifically sound test procedures and the cleanliness of volumetric glassware. These issues indicate a failure to assure drug products conform to appropriate standards of identity, strength, quality, and purity.