Does the proposed rule require that records be made available and accessible to FDA? 1.06K viewsOctober 10, 2022FDA 0 Sam Smith11.38K October 27, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted October 27, 2020 0 Comments Spread the loveYes. The proposed rule would require all records required by part 112 be readily available and accessible during the retention period for inspection and copying by FDA upon oral or written request (see proposed § 112.166). Spread the love Login