FDA 483 - Elite Medical Supply of New York, LLC - February 11, 2020

An FDA inspection of Elite Medical Supply of New York, LLC, a medical device specification developer in West Seneca, NY, identified a significant quality control issue. The firm's procedures for accepting incoming product were found to be inadequate. Specifically, the inspection revealed that the company's incoming inspection work instructions allowed for re-sampling and acceptance of a lot even if the initial sample failed to meet specified requirements.