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EIR
•Eurofins Analytical Laboratories, Inc.•November 7, 2016

Eurofins Analytical Laboratories, Inc. – FDA EIR, Nov 7, 2016

Record Details

An FDA surveillance inspection of Eurofins Analytical Laboratories, Inc. in New Orleans, LA, was conducted on November 7, 2016. The inspection, carried out under the Animal Drug Manufacturing Inspection Program (C.P. 7371.001) as part of FY17 workplans, aimed to assess the firm's operations. Eurofins operates as a control testing laboratory for food products and a research and development facility for medicated animal feeds. The company clarified it exclusively conducts testing for food products and performs research and development for medicated animal feeds, with no involvement in human or animal drug product testing.

During this one-day inspection, investigators found no objectionable conditions, and a facility walk-through revealed no insanitary issues. Consequently, no FDA Form 483, List of Inspectional Observations, was issued. Management was issued a Notice of Inspection (FDA 482), but no further significant discussions or regulatory actions were required. While a previous inspection in 2012 involved discussions about GMP issues, the current inspection concluded without any adverse findings or mandated corrective actions for Eurofins Analytical Laboratories, Inc.

Company
Eurofins Analytical Laboratories, Inc.
Inspection date
November 7, 2016
Product type
veterinary
Office
Office of Health Technology 7 (In Vitro Diagnostics)
People
  • Claire M. Minden (CO CDER OMQ)
  • Christopher N. Dedeaux
View Company Profile

ID · 98251d61-0ed2-4a91-83a0-59ca14ad6fdb

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