Becton Dickinson to validate lot "partialling" of plated media in response to FDA warning letter.
This article was originally published in The Gray Sheet
Executive Summary
BECTON DICKINSON LOT "PARTIALLING" OF PLATED MEDIA WILL BE VALIDATED, the company says in a Jan. 13 response to a Dec. 16 FDA warning letter. The process of "partialling" the in vitro diagnostics is intended to remove only portions of lots presumed contaminated prior to distribution.