FDA 483 - Pine Pharmaceuticals, LLC - September 30, 2024

Pine Pharmaceuticals, LLC in Tonawanda, NY, an outsourcing facility, was cited for significant deficiencies across its aseptic processing, environmental monitoring, and quality control systems during an inspection from August 5 to September 30, 2024. The firm failed to maintain adequate air quality, prevent microbiological contamination, and thoroughly investigate batch failures and product quality issues, including repeated observations from a previous inspection. These lapses led to the release of drug products with potential quality defects and a lack of robust process controls.