# FDA 483 - TriApex Laboratories Co., Ltd. - November 21, 2025

Source: https://www.keypedia.com/records/483/triapex-laboratories-co-ltd/6163e318-dc95-46d5-9f77-85da30e69c76

> FDA 483 for TriApex Laboratories Co., Ltd. on November 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TriApex Laboratories Co., Ltd.
- Inspection Date: 2025-11-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [Andrew R. Wasko](https://www.keypedia.com/people/andrew-r-wasko/87f194a2-d86b-4dad-8319-07f107ad8e6a)
- [investigator](https://www.keypedia.com/people/chelsea-w-lamm/d7a8dd67-dc26-4c8a-8e3c-aebc267cb775)

Company: https://www.keypedia.com/companies/triapex-laboratories-co-ltd/1d877304-3b0a-4fac-92f8-b5e57a056d5f

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8