# FDA 483 - Carolina Infusion - January 24, 2025

Source: https://www.keypedia.com/records/483/carolina-infusion/c3980467-1d71-4fe5-914b-059654564d63

> FDA 483 for Carolina Infusion on January 24, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Carolina Infusion
- Inspection Date: 2025-01-24
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Documents

- [483 - 2022-08-12](https://www.keypedia.com/records/483/carolina-infusion/25877f6e-2c42-4659-ad82-d719e4556ff8)
- [483 - 2022-08-12](https://www.keypedia.com/records/483/carolina-infusion/933a4fc2-d73b-4892-a87f-ca8a43493467)

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

Company: https://www.keypedia.com/companies/carolina-infusion/a1dadac6-a332-4476-b2f1-952c2a6cc5cf

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c