Nitto Avecia Pharma Services, Inc.January 24, 2020

FDA 483 - Nitto Avecia Pharma Services, Inc. - January 24, 2020

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Record Details

An FDA inspection of Nitto Avecia Pharma Services, Inc. in Irvine, CA, a contract testing laboratory, revealed significant deficiencies in laboratory controls. The firm's electronic data systems lacked adequate security to prevent unauthorized modification or deletion of raw data files, and procedures for audit trail review were insufficient. This indicates a serious concern regarding data integrity and the reliability of analytical results.

Company: Nitto Avecia Pharma Services, Inc.
Inspection Date: January 24, 2020
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
People: Claudia M. Perez-Kasmarski
Rumany C. Penn (Compliance Officer)

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ID · 68c42b34-1b01-4013-a3d4-d115b1a05740