FDA 483 - Nelson Laboratories Fairfield, Inc. - November 20, 2019

An FDA inspection of Gibraltar Laboratories, Inc. in Fairfield, NJ, a control laboratory testing facility, revealed significant deficiencies in laboratory control mechanisms. Observations included the use of uncontrolled personal notebooks for recording GMP data, a failure to conduct out-of-specification investigations for purified water, and incomplete laboratory records lacking essential raw data for bacterial endotoxin testing.