FDA 483 - Sun Pharmaceutical Industries Ltd. - June 13, 2025

Medi-Fare Drug Pharmaceutical Compounding, LLC, located in Blacksburg, SC, underwent an FDA inspection from May 19 to June 6, 2025. The inspection revealed several critical violations in their sterile drug manufacturing processes. Key issues included inadequate procedures to prevent microbiological contamination, as evidenced by contaminated HEPA filters and insufficient personnel training for detecting failing units. The facility also failed to maintain aseptic conditions, with residues and stains observed in ISO 5 hoods and inadequate cleaning and sanitizing procedures.

The inspection noted deficiencies in the design of the facility, which allowed material flow between unclassified and classified areas without proper monitoring of differential pressures. Alarm systems for air pressure differentials were not scientifically established or monitored. Environmental and personnel monitoring during aseptic processing were found lacking, with non-viable particle monitoring not performed continuously.

Additionally, the company relied on supplier certificates of analysis without validating the reliability of these reports, particularly concerning the sterility of water used in drug production. Investigations into batch failures were incomplete, lacking documented conclusions and follow-up actions. The stability testing program was discontinued in 2018, yet production of various drug products continued without determining appropriate expiration dates.

The FDA requires Medi-Fare Drug Pharmaceutical Compounding, LLC to address these deficiencies by establishing and following scientifically sound procedures, ensuring proper training, validating supplier reports, and reinstating stability testing to ensure compliance with regulatory standards.