Grand River Aseptic Manufacturing, Inc. (GRAM) (Booth 1543) 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 members proved that dedication to superior regulatory and quality performance is the only way to operate. We are thrilled to deliver this news to our clients and I congratulate the entire GRAM team on a job well done. Each year, our top five strategic objectives start with superior regulatory performance. Our company focus will always be on quality, and receiving zero 483s is a fantastic achievement.”
Interphex
Grand River Completes Fourth FDA Inspection
Found to be in compliance with cGMPs, passes Pre-Approval Inspection
