During a recent conversation with an experienced (albeit retired) process authority, he mentioned a requirement that process records for LACF must be documented and available to investigators in English. I've searched all relevant sections of the CFR that I can think of without success; the closest I found was guidance from FDA indicating that English documents may not be available in international facilities, but that copies not in English shall be collected for review by CFSAN.
To me, this implies that English documents would be available for FDA regulated plants within the US and therefore an expectation. Is this the case? Where can I find more information?
Edited by Bartholamew, 13 May 2022 - 06:29 PM.