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

This FDA Form 483, issued to Pine Pharmaceuticals, LLC, an outsourcing facility in Tonawanda, NY, following an inspection from August 5 to September 30, 2024, details nine observations of objectionable conditions.

**Key Violations and Observations:**

1. **Aseptic Processing Area Deficiencies (Air Supply):** * Open sterile product bottles were moved through non-HEPA filtered areas during Lidocaine HCL 4% Ophthalmic Solution production. * Lack of environmental monitoring in a critical transfer area. * Smoke study revealed turbulent airflow from capping to filling areas, increasing particulate risk. * Inadequate justification for air velocity and airflow patterns in laminar flow hoods (e.g., Hood (b)(4) 85-189 FPM, Hood (b)(4) 38-145 FPM). * Airflow visualization studies were insufficient, not performed under dynamic conditions, showed turbulent air, and smoke probe positioning was inadequate. * Dynamic smoke study from 9/14/23 was inadequate due to ISO 7 buffer room airflow concerns, a **repeated observation from 09/2023**. * Operators exhibited inadequate aseptic technique, including resting arms on ISO 5 hoods, working outside the hood, and product placement at the hood edge, a **repeated observation from