Breaking News

Grand River Completes Fourth FDA Inspection

February 10, 2016

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

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 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.”

Related Compliance:

blog comments powered by Disqus
  • CRO-Sponsor Partnerships

    CRO-Sponsor Partnerships

    Craig Morgan, Brand Development Director, goBalto Inc.||October 11, 2016
    10 tips for enabling better CRO and sponsor collaborations

  • The Human Parts of Mouse Models

    The Human Parts of Mouse Models

    Julia Schueler, Head of in vivo Operations, Oncotest, a Charles River company ||October 11, 2016
    The PDX model system has come back into focus

  • The Search &  Rescue Mission for Data Integrity

    The Search & Rescue Mission for Data Integrity

    Mike Jovanis, Vice President of Vault QualityDocs, Veeva Systems||October 11, 2016
    Cloud technology is essential for success