(FDAnews: Falls Church, VA) -- Despite the FDA’s ongoing work with international regulators to improve supplier quality issues, a top FDA official has stated that another public health crisis like Heparin, which occurred in 2010 when Baxter Healthcare distributed misbranded and contaminated doses of the drug, “seems inevitable.”

All together, the number of offshore suppliers has nearly tripled in recent years. China alone has nearly 1,000 makers of drug substances and only a small percentage of inspections.

Whether you make drugs or devices, biologics, or third-party goods, when your suppliers slip up, it’s you the FDA comes after. Ideally, regulators should be covering your back with tough inspections of offshore suppliers, but realistically, the agency simply is spread too thin to do the job.

Learn how to ensure the integrity and quality of your supply chain. Put yourself at the head of the class and avoid 483s (FDA warning letters) and lawsuits by taking the lead. You can take charge of your supply chain by joining the top speakers in Washington in August to learn about the tools you need.

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