Pine Pharmaceuticals, LLC – FDA 483, Oct 9, 2015

During an FDA inspection conducted from October 5-9, 2015, Pine Pharmaceuticals, an outsourcing facility in Tonawanda, New York, received a Form 483 detailing significant compliance deficiencies. The main violations included a failure to thoroughly investigate out-of-specification potency results for Vancomycin Injectable, especially after a freezer power loss, and an inadequate response to recurring complaints of crystalline structures in Bevacizumab syringes. Inspectors also noted deficiencies in aseptic processing areas, specifically clutter within an ISO 5 cleanroom. The facility was found to be releasing drug products, such as Vancomycin and Ceftazidime, without validating their potency testing methods. Additionally, product labels lacked essential information like inactive ingredients and adverse event reporting instructions, and the company failed to submit a complete report of all compounded products to the FDA as required by regulatory framework section 503B(b)(2)(A). Pine Pharmaceuticals is expected to implement comprehensive corrective and preventative actions to address these observations and ensure compliance with proper manufacturing practices and the quality of its compounded medications.