Eurofins EAG Materials Science LLCSeptember 24, 2019

FDA 483 - Eurofins EAG Materials Science LLC - September 24, 2019

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Record Details

Eurofins EAG Materials Science LLC, a contract testing laboratory in Maryland Heights, MO, received a Form 483 with three observations during an FDA inspection. The inspection revealed deficiencies in the investigation and documentation of unexplained discrepancies in batch records, inadequate controls over computer systems used for cGMP and GLP work, and a failure to provide complete requested records. These issues highlight concerns regarding the firm's quality system oversight and data integrity practices.

Company: Eurofins EAG Materials Science LLC
Inspection Date: September 24, 2019
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West II
Person: Michele Perry-Williams (Investigator)

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ID · d3ea7de1-e0fc-43e5-9b4c-56471f1d7465