FDA 483 - Larken Laboratories, Inc. - October 08, 2020

Larken Laboratories, Inc. in Canton, MS, was inspected and received a Form 483 with five observations primarily related to deficiencies in their post-marketing adverse drug experience reporting system. The firm failed to develop written procedures, review adverse drug experience information, and submit numerous quarterly and annual periodic adverse drug experience reports (PADERs) and individual case safety reports (ICSRs) in a timely manner. These issues indicate significant non-compliance with pharmacovigilance regulations.