The facility, which is located in San Diego, US, provides packaging, labeling, distribution and returns for pharmaceutical, biotechnology, medical device and dietary supplement companies.
Sherpa said that the FDB Investigators did not produce any notice of violations, which is their highest positive commendation, and will recommend a license be issued to the firm enabling it to store, distribute and produce secondary packaging for clinical trial materials.
Company president Mark Paiz said: "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.”
The contract packaging firm opened the facility just this month after signing a co-marketing agreement with neighbour Althea Technologies earlier in the year.
That deal will see Sherpa refer its contract packaging clients to Althea for their manufacturing needs, while the contract development and manufacturing organisation (CDMO) can offer access to labelling and packaging services.
At the time Althera spokeswoman said: "Contract packaging services offered through our co-marketing partner, Sherpa, will allow our clients to meet aggressive manufacturing timelines. We are very excited to present these capabilities to our existing and potential clients.”
Successful PIA
Approval for Sherpa’s facility continues a run of positive news for Althea which, just yesterday, was cleared by US authorities to manufacture a commercial parenteral product for the US market.
The clearance follows a pre approval inspection of Althea’s plant by the US Food and Drug Administration (FDA)
In a press statement Althea president Rick Hancock said: "We are very pleased with the successful outcome of our initial PAI and anticipate working with our clients to bring several other products to commercialization over the coming months."