This is to inform you that our site in Radebeul, Germany, was inspected by the US Food and Drug Administration (US-FDA) from 25. – 29. April 2016.
The audit has covered quality systems, equipment and facilities, materials, production, packaging, labeling and laboratory controls.
We are proud to announce that the inspection was concluded without the issue of a form 483.
This gives the evidence and proves again the continuous commitment of Arevipharma GmbH to operate in full compliance with the guidelines of good manufacturing practice (GMP) and maintain excellent quality standards.
Dr. Hendrik Baumann
Chief Executive Officer