FDA 483 Trend #2: International Inspections & FDA 483s on the Rise

The FDA is rapidly scaling up the number of inspections it conducts of foreign drug making plants. This year, the agency plans to complete about 2,000 international inspections, and the evidence suggests that this number will continue to grow in FY13.

Avoiding 483s in this environment may be tougher than in American plants, since the agency has more leeway than it does in the U.S. While its authority to inspect U.S. facility comes from Section 704 of the Food, Drug and Cosmetic Act—which requires it to defend its actions pretty thoroughly—its ability to inspect foreign plants comes from Section 801 of that Act. Under Section 801, the agency notes, officials are “not required to provide stringent documentary evidence to establish violations.” In other words, the standards for U.S. and foreign inspections differ significantly.

Some industry observers would call this a double standard. The Generic Pharmaceutical Association is pushing for new, uniform inspection systems, which would put domestic and foreign plants on the same schedule of inspections as U.S. plans. It would also like to see “risk-based” standards, which would focus foreign inspections on companies with questionable safety and compliance histories.

However, experts note that it’s simply financially unfeasible to cover the vast number of foreign manufacturing sites, which have emerged, especially in India and China. Foreign inspections are obviously much more costly, considering travel, security, and translation costs. Furthermore, one industry insider noted, “the document translation as well as the translations of discussions/questions is laborious at best.”

The FDA’s existing efforts have been focused on partnering with other agencies (e.g. the European Medicines Agency and the Therapeutic Goods Administration in Australia) on pilot programs for mutual acceptance of audits, thereby minimizing unnecessary duplication in the face of limited resources.

In other words, much as the FDA is ramping up inspections internationally, it will not be able to inspect facilities anywhere near the frequency at which U.S. sites are inspected.

That being said, when inspectors do go across the border for inspections, they will make it count. While consent decrees and product seizures are not applicable to those sites, import alerts certainly are (just ask Ranbaxy, Claris, and Aurobindo— all located in India).

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.

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  1. Pingback: International Inspections & FDA 483s on the Rise | GxP Systems

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