FDA Steps Up Enforcement Activities to Improve Management of Global Supply Chains

With more than 80 percent of APIs coming into the U.S. from foreign sites, the FDA is stepping up its enforcement activities to better manage global supply chains. At the same time, India and China are also expanding their inspection teams.

One powerful enforcement tool the FDA has is the power to restrict supplies coming into the U.S. via an import alert. To issue one, the agency only has to prove there is the appearance that a product is adulterated, Hyman, Phelps & McNamara Director Doug Farquhar told the DIA annual meeting in Washington, June 17.

Most import alerts were issued to firms in India, followed by China.

Most warning letters for GMP violations were issued to firms outside the United States, said Farquhar. From July 1, 2013, through May 26, 2015, the FDA issued 36 warning letters, 31 of which were for firms outside the U.S. Moreover, 22 of those warning letters were for data integrity issues, he said.

FDA Boosts China, India Staff

Not surprisingly, the FDA is boosting its staff in China and India. It expects to expand its China staff to 35 within the next two years and its India staff to 23 as the agency focuses on increasing inspections in both countries.

The agency’s China office currently boasts 12 Americans and two local staffers, said Leigh Verbois, incoming director of the China office. Growing the China office has been hampered by a Chinese visa process that could take up to two years, but that has recently been cut to just weeks, she told a session at the DIA annual meeting in Washington, D.C.

Meanwhile, the FDA’s India office is set to grow from 12 agency and four local staffers to 19 Americans and four locals, said Matthew Thomas, acting country director.

The FDA’s offices in India and China conduct preannounced and unannounced inspections but are focusing on the preannounced visits to build confidence with local drugmakers and educate them about FDA regulations.

Earlier this year, Indian officials accused FDA investigators of conducting unannounced inspections of drug manufacturers without Indian inspectors present. The FDA denied the allegations, saying it was working on plans to incorporate Indian investigators into the inspection process.

China Expands Overseas Inspections

Just as the FDA is ramping up drug inspections in China, Chinese regulators are increasing their oversight of overseas manufacturing operations, conducting 30 inspections so far in 2015.

The majority occurred in Europe, followed by India and the U.S., Qing Shen, principal technical advisor for Roche in Shanghai told the DIA annual meeting.

In 2014, the main observations were for quality control and assurance deviations, followed by facility issues. The only major critical violation China FDA found was a documentation issue, with quality control, production management and qualification and validation comprising the bulk of the 32 major violations observed, Shen said.

India Adds 147 Inspectors

Meanwhile, India’s national drugs authority is planning to hire 147 inspectors this year to ensure adherence to good manufacturing practices standards.

The new hires will inspect pharmaceutical facilities for their manufacturing processes, drug testing, storage methods and staff qualifications. They will also investigate cases of counterfeit or sub-quality drugs.

The June 22 announcement by the Central Drugs Standard Control Organization is part of a new five-year plan that has been anticipated, says Vince Suneja, CEO of TwoFour Insight Group.

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