On February 2nd, 2018, Creodent Prosthetics announced that its facility located in Manhattan, New York successfully passed an inspection by the US Food and Drug Administration (FDA).
The inspection carried out by a Senior FDA Inspector lasted 1 day. The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued. We are proud that our Quality Management Systems and 510(k) products passed all requirements.
It is an extremely satisfying result for our team and for our customers. A public report of the inspection will appear in the FDA database within 30 days.