FDA 483 - Intact Pharmaceuticals LLC - October 12, 2018

The FDA inspection of a facility producing 0.9% Sodium Chloride Solution for Injection revealed eleven observations.

**Facility and Operations:** The aseptic filling of 0.9% Sodium Chloride Solution for Injection occurs in a controlled, non-classified (CNC) environment, not the required ISO 5, with surrounding areas not classified to ISO 7.

**Violations and Observations:**

* **Aseptic Processing Area Deficiencies (Observation 1):** The facility lacks adequate controls for maintaining aseptic conditions. HEPA filters are not certified or periodically leak-tested, and air velocity specifications are absent. Airflow patterns were not directly tested, and studies showed turbulent airflow, failing to provide first-pass air over critical areas. Documentation for airflow studies was lacking, and HEPA filter performance over their lifecycle was not adequately managed, including a lack of decommissioning plans. A crack was observed in equipment intended to reduce operator and particulate contact. * **Environmental Monitoring Deficiencies (Observation 2):** Routine environmental monitoring for total particle counts, surface, and airborne viable sampling is not performed in filling rooms, equipment interiors, or ISO 8 formulation areas. Differential pressure between CNC and non-classified areas is not monitored. * **Aseptic Process Validation Deficiencies (Observation 3):** The aseptic process was not adequately validated. Test equipment lacked dedicated logs, preventive maintenance, and validated test methods. A deviation during validation involving incorrect equipment was not evaluated for its impact