U.S. inspectors have found new breakdowns at a Sun Pharmaceuticals plant in India that produces medications for U.S. customers, ProPublica reported July 16.
The FDA found the factory failed to identify the source of bacterial contamination in test samples and did not address damaged equipment that had caused drugs to be contaminated with metal particles, according to the June inspection report.
The findings come roughly two and a half years after the FDA allowed the facility to continue exporting selected drugs to the U.S., even after the factory was officially banned from the U.S. market.
Inspectors also cited that workers improperly handled vials and stoppers meant for sterile medications, and in some instances, there were lapses in disinfecting both the equipment and production areas, the report said. Investigators also said they saw liquid dripping through ceiling cracks, and that fungus and mold appeared to be present in a storage area for samples used for testing.
The inspection in June was the first time the FDA had been back to the factory since it imposed the import ban and Sun Pharma began shipping exempted medications to the U.S.
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