The US Food and Drug Administration (USFDA) has issued a warning letter to Natco Pharma, citing cleanliness and sterilization lapses at its Telangana plant. During an inspection in October 2023, the FDA found shortcomings in equipment maintenance and cross-contamination prevention. Natco’s cleaning procedures were deemed inadequate, risking product safety and quality. The FDA demanded a comprehensive assessment of the company’s deviation investigation system and staff competency. While Natco committed to halting US market drug production for remediation, FDA mandated notification before resuming operations.
US FDA Issues Warning to Natco Pharma Over Quality Control Violations
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