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...