FDA 483 - LNK International, Inc. - December 13, 2022

INK International, Inc. in Hauppauge, NY, received an FDA Form 483 citing deficiencies in equipment used for drug product manufacturing and storage. The firm failed to adequately design and qualify packaging equipment for commercial batches and did not formally qualify HVAC systems in its raw material and finished product warehouses. These issues raise concerns about product quality and stability.