Zero Form 483 Observations Issued
Grand Rapids, Mich., Nov. 7, 2018 – Grand River Aseptic Manufacturing, Inc. (GRAM), a leading parenteral contract development and manufacturing organization, is pleased to announce the successful outcome of its most recent inspection by the U.S. Food and Drug Administration (FDA). Following the inspection, conducted over eight days at GRAM’s facility in Grand Rapids, Mich., GRAM was found to be in compliance with Current Good Manufacturing Practices (cGMP), with no Form 483 observations issued.
“The outcome of our recent FDA inspection really underscores GRAM’s day-to-day commitment to quality excellence,” said Colleen Herczak, vice president of quality at GRAM. “The quality systems that we have built ensure that GRAM consistently delivers safe and effective products. This current achievement reflects an ongoing dedication to holding ourselves to the highest standards.”
GRAM’s regulatory history includes a strong record of cGMP compliance and FDA inspection approvals. At GRAM’s fill/finish facilities, quality systems are put through continuous audits that are conducted by internal personnel, clients and regulatory agencies such as the FDA.
“At GRAM, exceptional quality and regulatory compliance are our first priorities,” said Thomas J. Ross, president and CEO at GRAM. “I’d like to commend our team for their consistent dedication to high-quality work, which leads to outstanding results like these. Our next goal is to build upon this legacy of providing excellent service by expanding our capabilities while maintaining the same high-quality standards our customers count on.”
GRAM has experienced explosive growth since it opened its doors in January 2011. As an answer to this increasing demand, the company is in the process of building an additional $60 million facility expected to open in 2020. GRAM will be increasing its footprint to more than 100,000 square feet for clinical and commercial sterile manufacturing, analytical development and finishing. The new facility will enable GRAM to deliver high-speed manufacturing for all commercial batch sizes — small or large.
To learn more about GRAM, visit grandriverasepticmfg.com.
About Grand River Aseptic Manufacturing, Inc.
Grand River Aseptic Manufacturing, Inc. (GRAM), a parenteral contract development and manufacturing organization, delivers customized solutions to meet clients’ fill and finish needs from development through commercialization. With capabilities for biologics as well as controlled substances, GRAM’s expert project managers and modern facilities support pharmaceutical development and cGMP manufacturing, analytical testing and regulatory filing. For more information, visit grandriverasepticmfg.com.