FDA 483 - Carolina Infusion - January 24, 2025

This FDA Form 483 details six observations from an inspection, indicating significant deficiencies in aseptic processing and quality control.

**Observation 1:** Materials, specifically swabs for sterility testing, were exposed to air quality lower than ISO 5. Swabs were opened and placed in an ISO 7 area, or carried through an ISO 7 hallway, before being used in ISO 5 environments (Biological Safety Cabinet (BSC) and Laminar Airflow Hood (LAFH)). This compromises the sterility testing method, despite no reported positive growth, and cotton swabs may release particles during aseptic processing.

**Observation 2:** Routine environmental monitoring in ISO 5 areas (LAFHs and BSCs) is inadequate. While air sampling is conducted in ISO 7 rooms by a third party, active air monitoring and settle plates have never been used in the ISO 5 areas.

**Observation 3:** The firm failed to conduct media fills that accurately simulate aseptic production operations under worst-case, challenging, and stressful conditions.

**Observation 4:** Smoke studies were inadequately performed under dynamic conditions. The firm lacks documented evidence, records, or videos demonstrating that smoke studies in ISO 5 LAFHs or BSCs were conducted dynamically, despite a recent study on 12/30/2024.

**Observation 5:** Hazardous and highly potent drugs were produced without adequate containment, segregation, or cleaning of work surfaces, utensils, and/or personnel, raising