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

Source: https://www.keypedia.com/records/483/medi-fare-drug/887cab2d-d4c2-45fd-a5dd-5816a5ebf177

> FDA 483 for Medi-Fare Drug on June 07, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medi-Fare Drug
- Inspection Date: 2025-06-07
- Product Type: Drugs
- Office Name: Food and Drug Administration
- Summary: **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

## Related Documents

- [WARNING_LETTER - 2013-01-18](https://www.keypedia.com/records/warning_letter/medi-fare-drug/fbd734e8-c2e1-4431-b9eb-94613341af89)
- [483 - 2014-09-12](https://www.keypedia.com/records/483/medi-fare-drug/6c14a68e-8f61-49d0-8cac-2c3da3750565)
- [483 - 2013-01-18](https://www.keypedia.com/records/483/medi-fare-drug/9fbbde85-e81b-46ce-967a-e4a32aca2bfa)
- [483 - 2013-06-21](https://www.keypedia.com/records/483/medi-fare-drug/dfd72fe0-a143-4973-9009-2b58a4f6fb2b)
- [483 - 2023-05-26](https://www.keypedia.com/records/483/medi-fare-drug/7988832e-fad4-4006-be88-42f479b59ef6)

## Related Officers

- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

Company: https://www.keypedia.com/companies/medi-fare-drug/6fa558e8-65a8-455f-9f05-ea8f53028ea4

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516