FDA 483 - Nelson Laboratories Fairfield, Inc. - January 07, 2019

An FDA inspection of Gibraltar Laboratories, Inc., a control test laboratory in Fairfield, NJ, revealed a critical lapse in laboratory control systems. Specifically, a microbiologist pre-documented analytical results for USP<62> suitability testing without actually performing the test or allowing for proper incubation. This serious data integrity issue was only uncovered following a customer complaint.