The Investigator did not produce any notice of violations, which is their highest positive commendation. The Investigator stated that she will generate a report to the Food and Drug Branch recommending a license be issued to Sherpa to provide secondary packaging, storage and distribution of clinical trial materials. Under FDB regulations, in the absence of any notice of violation, Sherpa may now commence operations immediately upon the inspector's verbal approval.
"We are extremely pleased with the results of the FDB audit. The recommendation for license is a direct result of our thoughtful facility design and the sound Quality Systems we've implemented," said Mark Paiz, President of Sherpa Clinical Packaging.
Sherpa opened its new facility in June 2011 and is located adjacent to Althea Technologies, a contract development and manufacturing organization. As previously announced in March, Sherpa and Althea have entered into a co-marketing agreement.