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483
•TriApex Laboratories Co., Ltd.•November 21, 2025

TriApex Laboratories Co., Ltd. – FDA 483, Nov 21, 2025

Record Details

An FDA inspection of InApex Laboratories Co., Ltd, a nonclinical laboratory in Nanjing, China, revealed two significant observations. The firm was cited for inadequate equipment maintenance, specifically lacking documentation for routine cleaning and filter changes for cell incubators. Additionally, the quality assurance unit failed to accurately review a final study report, leading to discrepancies between reported results and raw data.

Company
TriApex Laboratories Co., Ltd.
Inspection date
November 21, 2025
Product type
drugs
Office
Office of Inspections and Investigations
People
  • Andrew R. Wasko
  • Chelsea W. Lamm (investigator)
View Company Profile

ID · 6163e318-dc95-46d5-9f77-85da30e69c76

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