Former FDA Investigator Speaks on Foreign Inspections

Former FDA Investigator gives an interview on his experiences inspecting foreign pharmaceutical manufacturers.

Former FDA Investigator, DeVaughn Edwards, was interviewed by the New York Times and detailed conditions Investigators experience while performing international inspections. In the interview, Edwards recalled an experience he endured while inspecting a pharmaceutical company in Taiwan. The article outlined challenges of FDA Investigators when performing inspections outside of the U.S.

In a recent discussion with Mr. Edwards, he stated that there are numerous challenges and concerns that are not as apparent to the public including language barriers and cultural differences. "Most companies have good intentions, whether you're looking at domestic or foreign companies. However, the exception is the concern. There are companies that may show you a pristine operation and flawless documentation and secretly subcontract production to other, substandard, operations." Mr. Edwards further commented that the due diligence to assure safe production of pharmaceuticals is the responsibility of industry and government alike. "The burden can't be on the government alone to prevent potentially contaminated or adulterated products from entering the marketplace. Industry must share the responsibility by performing on-site audits of their vendors, making quality their highest priority and informing regulatory authorities when they detect suspicious practices."

DeVaughn Edwards worked as an FDA Investigator for 14 years and performed inspections of pharmaceutical companies in 20 countries. During his FDA career, his inspections led to several Warning Letters and other official actions as well as numerous voluntary corrections. He currently works as an executive in the pharmaceutical industry. The New York Times article may be accessed at this link:
http://www.nytimes.com/2008/11/02/magazine/02fda-t.html?p...