FDA 483 - Pace Analytical Life Sciences - October 31, 2016

Bio-Concept Laboratories, Inc. in Salem, NH, a control testing laboratory, was cited with three observations during an FDA inspection. The firm failed to adequately requalify HPLC instruments, conduct timely and complete investigations into consumer complaints, and provide requested original documents during the inspection. These issues indicate significant deficiencies in quality control, investigation procedures, and record management.