PerkinElmer Reaches Agreement with FDA
PerkinElmer it has reached agreement with the U.S. Food and Drug Administration (FDA) whereby PerkinElmer will be permitted to resume production and shipment of newborn screening test kits at its Norton, Ohio facility.
Under the agreement, PerkinElmer will submit its newborn screening products to additional testing and label the products to advise users to perform tests in using the respective products.
“The quality and integrity of our products and services is our highest priority,” said Gregory L. Summe, Chairman and Chief Executive Officer, PerkinElmer, Inc. “Today’s announcement reflects our commitment to adhering to regulatory rules, tariffs and sanctions as part of our standard business practices, while ensuring our customers receive the best possible products at all times.”
Shipment and production of the PerkinElmer products from the Company’s Norton, Ohio facility will resume immediately.
