FDA EIR - Becton Dickinson & Co. - August 04, 2017

An FDA inspection of Becton Dickinson & Co. in Sparks, MD, occurred from July 31 to August 4, 2017. This was a post-market inspection for their BD Onclarity HPV Assay (PMA P160037) and a comprehensive review of their Quality System Regulation (QSR) compliance. The inspection identified two primary violations, documented on a Form FDA-483 issued to the VP of Quality Management. The first observation cited inadequate procedures for corrective and preventive actions (CAPA), specifically noting that four of seven reviewed CAPAs lacked proper effectiveness checks to ensure issue resolution and product safety, violating 21 CFR 820.100(a). The second observation pertained to insufficient procedures for controlling nonconforming products, as investigations into 17 instances of low product yield failed to adequately identify the root cause, contrary to 21 CFR 820.90(a). Additionally, management discussions highlighted inadequacies in process validations, design controls (including design input and colorblindness considerations for trays), documentation of executive management review attendance, and purchasing control inconsistencies. No voluntary corrections were initiated during the inspection, and the company stated a policy of not annotating the FDA-483, implying a formal written response addressing these findings will be necessary.