FDA 483 - Pine Pharmaceuticals, LLC - May 14, 2021

Pine Pharmaceuticals, LLC, an outsourcing facility in Tonawanda, NY, was inspected from 5/3/2021 to 5/14/2021. The inspection revealed significant deficiencies in quality control, including failures to thoroughly investigate out-of-specification results, inadequate procedures to prevent microbiological contamination of sterile products, and release of products based on unvalidated test methods. Additionally, the firm lacked proper laboratory controls and maintenance records for equipment calibration.