Becton Dickinson
Executive Summary
A Becton NDA could be held-up if sufficient corrections are not made at the company's Sandy, Utah plant, FDA cautions in warning letter issued July 1. The company is in the process of completing changes to the qualification and control of the ambient temperature and accelerated temperature stability rooms. Becton anticipates validation of packaging lines protocol will be completed at the end of September. Batch production and control records have been modified and changes submitted to FDA