Tesa Labtec, a German patch and oral thin film maker, has completed a Pre-Approval Inspection (PAI) by the U.S. FDA in February 2016. 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.

The FDA visited both the R&D site in Langenfeld as well as the manufacturing facility in Hamburg, Germany. FDA provided feedback with a short list of observations, which the company plans to promptly address. The FDA Investigator said that the initial conclusion was to approve the sites for commercial activities, which must still be reviewed by the FDA.

“This FDA inspection demonstrates a significant milestone within our plan to expand our business to the U.S. market,” said 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.”