US FDA inspectors found serious violations at Hetero Labs in India, including birds and lizards in storage areas. FDA conducts 15,000 inspections annually, with 1,800 citations in 2024. This presents opportunities for contract manufacturers, equipment suppliers, and compliance service providers in the pharmaceutical industry.

Hetero Labs’ facility manufactures critical drugs for Pfizer and Novartis. Pfizer’s Paxlovid supply chain faces challenges due to regulatory issues with Hetero. Novartis also relies on Hetero for manufacturing diclofenac sodium. Regulatory events trigger urgent supply chain reviews and vendor qualification processes for pharmaceutical companies.

Pharmaceutical companies must quickly identify alternative manufacturers to meet quality standards in case of supply constraints. Regulatory events offer competitive intelligence advantages to manufacturers. Service providers in environmental monitoring, laboratory equipment, and compliance solutions see increased demand during facility remediation efforts.

FDA plans to expand unannounced inspections at international facilities after finding more deficiencies in foreign firms despite advanced notice. Leading pharmaceutical CMOs and suppliers rely on real-time insights to succeed. GlobalData’s Sales Intelligence solution provides critical data-driven insights for CMOs, equipment suppliers, and consultants.

Pharmaceutical supply chain organizations must invest in advanced intelligence capabilities to turn regulatory events into business opportunities quickly. GlobalData offers Sales Intelligence solutions to help organizations capitalize on market opportunities. Advanced intelligence capabilities are crucial for success in the pharmaceutical supply chain industry.

Read more at Yahoo Finance: FDA inspection reveals critical supply chain vulnerabilities