FDA 483 - EMSL Analytical, Inc. - September 29, 2023

EMSL Analytical, Inc. in Cinnaminson, NJ, a contract testing laboratory, received a Form 483 with two observations. The inspection revealed deficiencies in employee training for current good manufacturing practices and a failure to adequately follow quality control unit procedures, including the timely review of Standard Operating Procedures. These issues indicate a lack of adherence to established GMP protocols.