Natco Pharma, a leading pharmaceutical company based in Telangana, has come under scrutiny from the US Food and Drug Administration (USFDA) for multiple violations observed at its manufacturing facility in Kothur Village, Telangana. The US health regulator cited concerns regarding cleanliness, sterilization practices, and equipment maintenance at the plant, prompting the issuance of a warning letter to the company.
During an inspection conducted from October 9 to 18, 2023, USFDA investigators identified various deficiencies at Natco Pharma’s finished pharmaceuticals plant. The warning letter highlighted lapses in maintaining cleanliness standards, sterilizing equipment and utensils at appropriate intervals, and inadequate cleaning procedures for non-dedicated equipment.
The USFDA noted that Natco Pharma’s cleaning procedures were insufficient to prevent malfunctions or contamination that could compromise the safety, identity, strength, quality, or purity of the drug products. Moreover, cross-contamination concerns were raised, indicating that control samples and placebo batches failed to adequately demonstrate freedom from contaminants originating from visibly dirty equipment.
Furthermore, the US health regulator criticized Natco Pharma for its inadequate investigation of discrepancies or failures in batch production and components. The company was urged to conduct a comprehensive, independent assessment of its deviation investigation system, including competencies of staff, root cause analysis effectiveness, and corrective and preventive action (CAPA) protocols.
In response to the warning letter, Natco Pharma committed to temporarily suspending production of all drugs manufactured on both dedicated and non-dedicated equipment for the US market. The company pledged to remediate the Current Good Manufacturing Practice (CGMP) violations and agreed to notify the USFDA before resuming any manufacturing operations.
A warning letter from the USFDA is issued when significant violations of regulatory standards are identified during inspections. India, being a major hub for pharmaceutical manufacturing, boasts the highest number of USFDA-compliant pharma plants outside the US. With over 600 USFDA-registered manufacturing sites, India constitutes approximately 12.5% of all registered manufacturing sites operating globally.
The issuance of the warning letter underscores the importance of stringent adherence to quality standards and regulatory compliance in pharmaceutical manufacturing. Natco Pharma’s commitment to addressing the identified violations and ensuring remediation reflects the industry’s collective efforts to uphold safety and quality standards in drug production.
