FDA 483 - Pine Pharmaceuticals, LLC - September 19, 2023

An FDA inspection of Pine Pharmaceuticals, LLC in Tonawanda, NY, from September 6-19, 2023, revealed significant deficiencies across multiple areas. The firm's quality control unit lacked proper authority and failed to adequately investigate product defects, batch failures, and complaints, including those related to particulate matter. Additionally, the inspection identified issues with aseptic processing, environmental control, facility cleanliness, and a failure to report compounded drugs to the FDA.