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Mock FDA audit for foreign companies via SKYPE

by MDI Consultants Inc.

Foreign companies should be prepared for FDA inspections of the operations. Having a consultant on site with extensive FDA experience is the best way to go. The second best way to be prepared for an FDA inspection is having an audit via a SKYPE connection. We will run though your documents and provide insight into the FDA inspection methods and what they are keying into during the inspection. We will assist in updating your quality system to meet with the FDA QSR/cGMP requirements. Audits can run for a period of a week with review of documents and having a training program on FDA regulatory compliance. We have found that this type of audit can result in much better FDA inspection outcomes.

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