FDA 483 - Ascend Laboratories, LLC - November 10, 2021

Ascend Laboratories, LLC in Parsippany, NJ, was inspected by the FDA, revealing significant deficiencies in post-marketing adverse drug experience reporting and annual report submissions. The firm lacked written procedures for adverse drug experience reporting and failed to submit numerous periodic adverse drug experience reports and annual reports in a timely manner. These issues indicate a systemic problem with regulatory reporting compliance.