Successful Completion Of 4th FDA Inspection
February 10, 2016 – Grand River Aseptic Manufacturing, Inc. (“GRAM”) is proud to announce the successful completion of its fourth Food and Drug Administration (FDA) inspection at its contract parenteral manufacturing facility in Grand Rapids, MI.
The seven-day FDA inspection included a general GMP and a Pre-Approval Inspection. At the conclusion of the inspection, GRAM was found to be in compliance with Current Good Manufacturing Practices and passed the Pre-Approval Inspection, with no Form 483 observations issued.
At the completion of the inspection, Tom Ross, President and CEO 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.”
The outcome of the inspection shows GRAM’s commitment to delivering a quality product to its clients. In addition to the explosive growth the company is experiencing, being compliant with FDA principles and regulations remains at the top objective for all GRAM team members. GRAM views its relationship with the FDA as a partnership and this latest achievement demonstrates the success of operating in that manner.
COO Connie Degen stated, “Since the company was formed in December 2010, GRAM has successfully completed all four of our FDA Inspections, with this last one being the most successful. We welcome the FDA’s return each year and are proud to demonstrate our dedication to following cGMPs and to the quality of our client’s products. This is a crucial step for GRAM’s positioning in the industry as a leading contract manufacturing organization.”
Grand River Aseptic Manufacturing
Grand River Aseptic Manufacturing (GRAM) is a parenteral contract manufacturing organization supporting new product development and cGMP manufacturing. With a state-of-the-art cleanroom and highly trained staff, GRAM provides clinical trial and commercial material in vials or syringes for the life sciences industry.
GRAM specializes in pre-clinical, clinical, and commercial manufacturing and offers the following services: sterile product development and manufacture, lyophilization, terminal sterilization and analytical and microbiological testing, stability sample storage, labeling and packaging storage and distribution.