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.