EMSL Analytical, Inc.September 29, 2023

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

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Record Details

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.

Company: EMSL Analytical, Inc.
Inspection Date: September 29, 2023
Product Type: Drugs
Office: New Jersey District Office
Person: Kristina L. Conroy (Investigator)

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ID · 8f0fcef9-3403-4408-a817-26328c6958cf