FDA 483 - LEESAR, INC - May 09, 2025

**FDA 483 Summary for Executives**

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

**Main Violations/Issues:** 1. **Microbiological Contamination Prevention:** Procedures to prevent contamination in sterile drug products are not adequately established or followed. Contaminated HEPA filters and inadequate personnel training were observed. 2. **Aseptic Processing Deficiencies:** Cleaning and disinfecting systems in aseptic areas are insufficient, with residues and stains noted on work surfaces. There is a lack of confirmation and maintenance of cleanliness in ISO 5 environments. 3. **Facility Design and Control Systems:** The facility"s design allows material flow between unclassified and classified areas without proper monitoring, risking contamination. 4. **Environmental Monitoring:** Inadequate monitoring of personnel and environmental conditions during aseptic processing, with insufficient non-viable particle monitoring. 5. **Supplier Analysis Validation:** Reliance on supplier reports without validating their accuracy, particularly concerning sterile water used in production. 6. **Investigation Records:** Incomplete documentation of investigations into batch failures, with inconclusive root causes and insufficient corrective actions. 7. **Stability Testing:** The stability program was discontinued in 2018, yet production continued without determining appropriate expiration dates. 8. **In-Process Controls:** Lack of established procedures for in-process controls and testing of materials.

**Regulatory Framework:** The observations are based on FDA regulations for sterile drug manufacturing, focusing on maintaining aseptic conditions and ensuring product safety and efficacy.

**Required Actions:** Medi-Fare Drug Pharmaceutical Compounding, LLC must address these deficiencies by establishing and following robust procedures for contamination prevention, aseptic processing, environmental monitoring, and supplier validation. Corrective actions should be documented, and stability testing programs must be reinstated to ensure compliance with FDA standards.