The German patch and oral thin film maker announces the completion of a Pre-Approval Inspection (PAI) by the U.S. Food and Drug Administration (FDA) in February 2016.
During a total of 7 days of inspection, the FDA visited both the R&D site in Langenfeld as well as the manufacturing facility in Hamburg, Germany. The FDA provided feedback with a short list of observations which tesa Labtec takes seriously. At the conclusion of the inspections, the FDA Investigator said that the initial conclusion was to approve the sites for commercial activities. That conclusion must still be reviewed within FDA. The company is responding promptly to the observations which the Investigator raised.
“This FDA inspection demonstrates a significant milestone within our plan to expand our business to the U.S. market.” stated Dr. Ingo Lehrke, Managing Director of tesa Labtec. “The inspection paves the way to the U.S. market for our customers’ transdermal patches and oral thin films and certifies the high quality of our development and manufacturing capabilities. This achievement was made possible through the dedication of our talented staff.”
The PAI was triggered by a customer’s ANDA filing for a transdermal patch, which is manufactured by tesa and is designated for U.S. distribution.