FDA Cites Natco Pharma for Manufacturing Violations, Risking Drug Contamination

FDA issues warning to India's Natco Pharma for manufacturing lapses, highlighting importance of CGMP compliance in global pharma supply chain.

Dil Bar Irshad
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FDA Cites Natco Pharma for Manufacturing Violations, Risking Drug Contamination

FDA Cites Natco Pharma for Manufacturing Violations, Risking Drug Contamination

The US Food and Drug Administration (FDA) has issued a warning letter to Natco Pharma, an India-based pharmaceutical company, for failing to maintain proper cleanliness and sterilization procedures at its finished pharmaceuticals plant in Telangana, India. The FDA conducted an inspection of the facility from October 9 to 18, 2023 and observed several violations of current Good Manufacturing Practice (CGMP) regulations.

According to the warning letter, Natco Pharma had inadequate cleaning procedures for non-dedicated equipment, failed to investigate discrepancies or failures of batches to meet specifications, and lacked proper investigation competencies and root cause analysis. These deficiencies jeopardize the safety and quality of the company's products, potentially leading to drug contamination.

In response to the FDA's findings, Natco Pharma has committed to temporarily suspending production of all drugs manufactured on both dedicated and non-dedicated equipment for the US market while it works to remediate the CGMP violations. The company must notify the FDA before resuming any manufacturing operations.

Why this matters: India has the highest number of FDA-compliant pharmaceutical plants outside the US, with over 600 registered manufacturing sites accounting for nearly 12.5% of all foreign FDA-registered facilities. Violations at Indian drug manufacturing plants can have significant implications for the global pharmaceutical supply chain and patient safety.

The FDA's action against Natco Pharma comes amidst increased scrutiny of pharmaceutical manufacturing practices. In a separate case, Checkpoint Therapeutics, Inc. is facing a class action lawsuit alleging that the company made false and misleading statements about its oversight and manufacturing standards, which led to FDA approvability issues for its lead product candidate, cosibelimab.

"Natco's management acknowledges the seriousness of the observations cited in the warning letter and is fully committed to resolving these issues at the earliest," the company stated in a press release. The FDA will continue to monitor Natco Pharma's corrective actions and has instructed the firm to hire a qualified consultant to assist in remediation efforts. The warning letter underscores the importance of strict adherence to CGMP regulations to ensure the safety and quality of pharmaceutical products.

Key Takeaways

  • FDA issued warning letter to Natco Pharma for CGMP violations at India plant.
  • Natco Pharma suspending US drug production to remediate issues cited by FDA.
  • India has over 600 FDA-compliant plants, violations impact global supply chain.
  • Checkpoint Therapeutics faces lawsuit over false statements on manufacturing.
  • FDA emphasizes strict CGMP adherence to ensure pharmaceutical product safety.