FDA 483 - Medi-Fare Drug - June 07, 2025

**FDA 483 Summary for Executives**

**Company:** Medi-Fare Drug Pharmaceutical Compounding, LLC **Inspection Dates:** May 19, 2025 - June 6, 2025 **Location:** Blacksburg, SC **Inspection Type:** Sterile Drug Manufacturer

**Key Violations/Issues:**

1. **Microbiological Contamination Prevention:** The company lacks established procedures to prevent microbiological contamination in sterile drug products. Contaminated HEPA filters and inadequate personnel training for detecting failing units were noted.

2. **Aseptic Processing Deficiencies:** The cleaning and disinfecting systems for aseptic conditions are inadequate. Residues and stains were observed on work surfaces, and the cleanliness of ISO 5 environments is not consistently maintained.

3. **Facility Design and Control Systems:** The facility design allows material flow between unclassified and classified areas without proper monitoring, risking contamination. Air pressure differential alarms are not scientifically validated or monitored.

4. **Environmental Monitoring:** The system for monitoring environmental conditions during aseptic processing is deficient. Personnel and non-viable particle monitoring are not scientifically established or consistently performed.

5. **Supplier Validation:** The company accepts supplier analysis reports without validating the reliability of these reports, particularly for sterile and nonpyrogenic water used in production.

6. **Investigation Records:** Investigations into batch failures lack thorough conclusions and follow-up actions. Particulate matter was found in syringes, and previous microbial contamination issues were not adequately addressed.

7. **Stability Testing:** The stability program was discontinued in 2018, yet production continues without testing for appropriate expiration dates.

8. **In-Process Controls:** Written procedures for in-process controls and testing are not established or followed.

**Regulatory Framework:** The observations are based on FDA regulations for sterile drug manufacturing, focusing on contamination prevention, facility design, environmental monitoring, and quality assurance.

**Required Actions:** Medi-Fare Drug Pharmaceutical Compounding, LLC must address these