controlledenvironments-terrauniversal.pptVIP

* * * * * * * * * * * * A few months after this meeting, in July 2014, the FDA published a draft Guidance document that would generally explain their expectations of outsourcing facilities. * In a recent draft guidance document, the FDA announced their expectations for outsourcing facilities. The key point to understand about this draft guidance is these documents are simply the EXPECTATIONS of the FDA during the interim period until they write a more definitive guidance document. This is important because, as you may know, the FDA has already started inspecting registered 503B Outsourcing