FDA 483 - Lornamead Inc. - April 11, 2023

Lornamead Inc., a drug manufacturer in Tonawanda, NY, was inspected and cited for significant deficiencies across multiple areas. These include failures in raw material identity testing, inadequate complaint handling for adverse events, insufficient investigations into out-of-specification results, lack of proper temperature control for storage, and non-adherence to procedures for managing rejected drug products. The observations indicate a need for comprehensive improvements in their quality control and manufacturing processes.