FDA 483 - Fagron Compounding Services - August 08, 2025

**FDA 483 Summary: Fagron Compounding Services**

**Company Name:** Fagron Compounding Services **Inspection Dates:** July 29, 2025 - August 8, 2025 **Location:** Wichita, KS **Inspection Type:** Outsourcing Facility

**Main Violations/Issues:**

1. **Microbiological Contamination Prevention:** The facility lacks established, written, and followed procedures to prevent microbiological contamination in sterile drug products. Notably, drugs were produced and released after failed media fills without successful revalidation of aseptic processes.

2. **Aseptic Process Simulations:** Media fill records were found inaccurate, with discrepancies in pre and post-incubation weights. Media fills were not representative of actual aseptic processes, lacking challenges for unplanned interventions during production.

3. **First Pass Air Disruption:** Observations showed operators disrupting first pass air in critical production areas, with no rejection or clearance of potentially contaminated materials.

4. **Tool Control and Sterilization:** Tools used during aseptic production were inadequately controlled and sanitized, with instances of operators reaching over critical areas, blocking first pass air.

5. **Equipment Handling:** Sterilized equipment components were not opened in ISO-5 classified areas, compromising sterility.

6. **Inadequate Airflow Pattern Analyses:** Smoke studies revealed non-unidirectional airflow in critical ISO-5 environments, with turbulent air entering from surrounding areas.

**Regulatory Framework:** The inspection was conducted under the regulatory framework governing outsourcing facilities, focusing on compliance with Current Good Manufacturing Practice (CGMP) requirements.

**Required Actions:** Fagron Compounding Services must address the identified deficiencies by implementing corrective actions to ensure compliance with CGMP standards. This includes revising and enforcing procedures to prevent contamination, ensuring accurate and representative media fills, maintaining sterile conditions, and conducting thorough airflow analyses. The company is expected to communicate objections or corrective actions to the FDA promptly.