Manufacturing Site Change Supplements: Content and Submission
Title:
Manufacturing Site Change Supplements: Content and Submission
Origin/Publisher:
FDA
Document Type:
Gudeline
Content:
This guidance explains FDA’s current thinking regarding the following:
(A) What constitutes a manufacturing site change and when you should submit a PMA supplement for a site change;
(B) What documentation you should submit in a site change supplement; and
(C) The general factors FDA intends to consider when determining whether to conduct an establishment inspection prior to approval of a site change supplement.