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Grand River Completes Fourth FDA Inspection

Found to be in compliance with cGMPs, passes Pre-Approval Inspection

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By: Kristin Brooks

Managing Editor, Contract Pharma

Grand River Aseptic Manufacturing, Inc. (GRAM) has successfully completed its fourth FDA inspection at its contract parenteral manufacturing facility in Grand Rapids, MI.   The seven-day inspection included a general GMP and a Pre-Approval Inspection, which found GRAM to be in compliance with Current Good Manufacturing Practices. GRAM also passed the Pre-Approval Inspection, with no Form 483 observations issued.    Tom Ross, president and chief executive officer at GRAM said, “GRAM team memb...

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