FDA strengthens import inspections

February 12, 2010
Erik Greb

See Erik Greb's bio page.

Pharmaceutical Technology Europe

The FDA has unveiled a new program to improve the efficiency of import inspections.

The FDA has unveiled a new program to improve the efficiency of import inspections. The Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT) information-technology system allows border inspectors to reliably monitor products at the port of entry and to focus inspections on shipments that pose the greatest risk.

In a speech to the Center for Strategic and International Studies, Margaret Hamburg, Commissioner of the FDA, explained that PREDICT uses various criteria to rank import shipments according to risk. The system evaluates whether a product is intrinsically risky and considers data obtained during previous examinations of shippers and producers. The agency can add information about factors such as floods, hot weather, or market conditions that raise a particular shipment’s risk of being spoiled or shoddy. The information is assembled and converted to a risk score for each shipment and investigators will check the riskiest items first.

The PREDICT system automatically flags potentially risky shipments and gives low risk scores to innocuous materials, which can then be cleared rapidly through FDA inspection. According to Hamburg, the system will allow FDA inspectors to devote their attention to high-risk items. Carefully labeled products with good histories should experience only brief delays before entering the country.

The new system will help the FDA deploy its resources strategically and cope with an expanding mandate. Investigators “will still be checking only a small percentage of all import shipments,” said Hamburg in the speech, “but they’ll be using better intelligence to decide which shipments to check.” FDA piloted PREDICT in Los Angeles and is now installing it in New York. The system is expected to be running around the country by the end of spring 2010.

PREDICT is one part of an ongoing overhaul of the agency’s approach to ensuring drug safety. “We are moving from a system that places most of the regulatory burden on the FDA’s modest inspection force to one that creates greater oversight at points further back along the production chain,” said Hamburg. She also added that the challenges of globalization require international cooperation to establish a “global safety net”.

In addition, the FDA seeks to hold importing companies responsible for their supply chain. Hamburg said: “Companies must be able to effectively demonstrate that safety, quality, and compliance with international and US standards are built into every component of every product and every step of the production process."

www.fda.gov