There really is no excuse for receiving a Form 483 observation for management review.
In this edition of Devine Guidance (DG), Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.180 (General Requirements). General requirements are boring; however, just like basic blocking and tackling drills in football, device manufacturers must get the basics correct.
Distribution and installation are extremely important processes that ensure approved, safe, and effective medical devices make it into the hands of healthcare practitioners. In this edition of Devine Guidance (DG), Dr. D continues with his guidance for 21 CFR, Part 820, Subpart – L (Handling, Storage, Distribution, and Installation), specifically 820.160 (Distribution) and 820.170 (Installation).