Sun Pharmaceutical Industries faced FDA scrutiny after inspectors found major contamination issues at its manufacturing facility in India. The discovery of metal shavings and contaminated vials prompted a ban on exporting drugs to the U.S., raising serious concerns about the safety of medications. Despite such severe violations, the FDA chose to permit Sun Pharma to continue operations, citing worries over potential medication shortages in the American market, demonstrating a conflict between regulatory enforcement and public health needs.
Sun Pharma's factory faced severe scrutiny after inspectors found contamination, leading to a ban on exportation to the U.S., highlighting the conflict between safety and drug supply.
Despite the egregious violations found in their manufacturing practices, the FDA allowed Sun Pharma to continue operations due to concerns over medication shortages in the U.S. market.
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