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Question
Does U.S. F.D.A. emits GMP certificates(cGMP Pharma Industry) for foreign countries? Let me explain myself. I have asked for GMP certificate, to a supplier from INDIA, and he gave me a warning letter from FDA. I've search the FDA inspection database and i find this suplier within de VAI classification(voluntary action indicated). How I know if the company from India complies with cGMP

Answer
Jose:

When FDA inspects an overseas company they can either issue a decision of "No Action Indicated" (NAI) meaning that the company has no or minor issues that will be fixed and that FDA is basically 'happy' with the company; or "Voluntary Action Indicated" (VAI) meaning that the company has some GMP issues but FDA believe the company has the ability and desire the fix the issues observed, but FDA will follow-up with a re-inspection; or "Official Action Indicated" (OAI), meaning that FDA is very unhappy and the company will face further official FDA action, such as a Warning Letter or a ban on imports to the USA from the company.

If your Indian company has received a Warning Letter from FDA, and you intend to use their raw material(s) in a product you will be selling in the USA, then FDA might ban the import of your product into the USA.

My recommendation is to cease using your Indian Supplier until such time that the FDA warning database shows that the Warning Letter has been resolved (closed).  

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Michael Anisfeld

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Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements

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