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FDA Negligent in Inspecting Foreign Drug Plants

  

Feb 17, 2017

    

It would appear that the FDA is ignoring “Drugs” in their Agency title.

A report in the January 30th edition of Chemical & Engineering News cites a Government Accountability Office report which documents that the Agency has failed to inspect 1,300 drug-manufacturing facilities in foreign nations exporting to the U.S.  A total of 243 of  535 pharmaceutical facilities in China have yet to be inspected. 

  

Approximately one-third of 600 pharmaceutical plants in India have not been evaluated by FDA personnel.  The report noted that 90 percent of 171 facilities in South Korea have not been reviewed in on-site visits.

Apparently, the FDA uses a risk-based system to prioritize visits but the agency is chronically under-staffed.

Peter Saxon, president of a consulting group with extensive ties to foreign manufacturers indicated that most of the uninspected plants produce over-the-counter (OTC) products.

If the FDA can expend time and energy in inspecting egg-producing farms following the implementation of the Salmonella Prevention Final Rule and finding virtually no SE even in 2011. The Agency should have the resources to audit manufacturing facilities manufacturing both generic and OTC drugs.

EGG-CITE has frequently noted the deficiencies in establishing priorities and execution of responsibilities for protection of consumers. The FDA as presently staffed and structured cannot do justice to both food and drugs. The U.S. would be better served by separate Food Safety and Drug Agencies with concentration on their specific areas of concern.