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Jan 2015


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FDA's Foreign Inspections Requires Special Management

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Event Overview: 

Foreign manufacturers face special difficulties when FDA conducts an inspection. The logistics of scheduling an inspection involve much more than firms realize and involves interaction with other federal agencies. Although foreign manufacturers and U.S. manufacturers must conform to the same manufacturing requirements, there are language barriers.

There may be misunderstandings during an inspection that create needless problems. A foreign firm's response to an inspection plays a critical role in how FDA evaluates the firm, something many foreign firms failure to appreciate. Some foreign firms truly do not understand the devastating consequences to their U.S. market. Foreign firms need to develop a strategy for how they prepare for an inspection, how to conduct an inspection and how to respond to an inspection. A failure in any of these steps may lead to the firm being placed on an Import Alert, which closes the U.S. market until the firm passes an inspection. That process does not happen quickly. For international commerce, that kind of delay translates into a big hit on the balance sheet. 

Why Should you Attend: Foreign manufacturers face special problems when the FDA inspects their manufacturing operations. Arranging for a foreign inspection requires extensive logistical planning by the FDA and the firm. Foreign inspections are an expensive proposition for FDA to conduct. The FDA is not eager to spend its inspectional assets on a firm's compliance failures. What happens when you agree to be inspected and you fail the inspection? Your firm will most likely be prohibited from shipping product to the U.S. If you were not ready for the FDA's inspection and the FDA documented that you were out of control, what is your immediate strategy? How will you work with or in spite of the FDA? Plan on having your products refused entry into the U.S. until you finally have a successful inspection. More importantly, how can you make sure you have turned a regulatory corner with FDA and be back in business with the U.S.? 

One special pitfall foreign firm's face involves translating records and conversations accurately into English. If you do not know how to say it in English, it becomes meaningless. Foreign facilities need to develop exacting criteria to select their translators. Firms may need to consider a third party audit prior to agreeing to an inspection by the FDA. The question there is credibility for your purposes. A false sense of security may be your undoing. The cost of making mistakes or taking missteps with FDA becomes enormously expensive for foreign firms. Business plans turn into a three-year plan of recovery. That's not where a foreign firm wants to be. 

Areas Covered in the Session:

  • The purpose of foreign inspections
  • Preparing for the inspection
  • English translation and a translator
  • Regulations, records and problems
  • Managing inspectional observations (FDA Form 483)
  • Prohibited imports - Import Alerts
  • Fixing the problem

Who Will Benefit:

  • Regulatory Affairs
  • Quality Assurance
  • Manufacturing
  • Initial importers
  • Foreign exporters
  • Import brokers
  • Freight forwarder

Speaker Profile:

Casper Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. 


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