Pine Pharmaceuticals, LLC – FDA Warning Letter, Nov 14, 2025

Pine Pharmaceuticals, LLC, an outsourcing facility in Tonawanda, NY, was issued a formal Warning Letter by the FDA following an inspection conducted between November 4 and November 14, 2025. The investigation revealed significant safety and quality control failures that violate the Federal Food, Drug, and Cosmetic Act (FDCA) and put patients at risk.

The primary violations involve producing drugs under insanitary conditions and failing to adhere to Current Good Manufacturing Practice (CGMP) standards. Inspectors observed staff failing to properly sanitize their hands, sleeves, and equipment before entering sterile production areas. Furthermore, the facility’s environmental monitoring program was inadequate, failing to test high-touch equipment for potential contamination. The firm also failed to thoroughly investigate products contaminated with visible fibers and particles, often relying on re-inspections to release batches rather than identifying the root cause of the failures.

Additional issues included unvalidated manufacturing processes, poor oversight of yield calculations, and insufficient training for staff responsible for quality inspections. These deficiencies were noted as repeat violations from previous inspections in 2021, 2023, and 2024, indicating a systemic failure in quality oversight.

The FDA requires Pine Pharmaceuticals to provide a written response within 15 working days detailing their corrective actions and evidence of improvements. The agency strongly recommends hiring a third-party consultant to conduct a comprehensive assessment of the facility’s operations and sterile processing systems. Failure to address these concerns could result in legal action, such as product seizures or injunctions.