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Logo Made in Germany BIO 2017

Successful FDA Pre-Approval Inspection

During a total of 7 days of inspection, 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 tesa Labtec takes seriously. At the concluding sessions 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. tesa Labtec has responded promptly to the observations which the Investigator had raised.

“This FDA inspection demonstrates a significant milestone within our plan to expand our business to the US market.” stated Dr. Ingo Lehrke, Managing Director of tesa Labtec. “The inspection paves the way to the US 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.” Dr. Lehrke concluded.

The PAI was triggered by a customer’s ANDA filing for a transdermal patch, which is manufactured by tesa and is designated for US distribution.

For any questions please contact:
Klaus Köhl
Director Business Development & Licensing
E-Mail:bd.tesa-labtec@tesa.com
Phone: +49 2173 97350

Exhibitor: tesa Labtec GmbH

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