# FDA 483 - GLPGCP Development (Asia) Pte. Ltd. - May 18, 2026

Source: https://www.globalkeysolutions.net/records/483/glpgcp-development-asia-pte-ltd/3a0a3c58-fa17-4496-9fd8-425c92f62a60

> FDA 483 for GLPGCP Development (Asia) Pte. Ltd. on May 18, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GLPGCP Development (Asia) Pte. Ltd.
- Inspection Date: 2026-05-18
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Ningbo Hecai Medical Equipment Co. Ltd., a medical device manufacturer in Ningbo Zhejiang, China, identified a significant quality system deficiency. The inspection revealed that the firm's procedures for corrective and preventative actions were not adequately established. This finding indicates a fundamental issue in the firm's quality management system.

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## Related Officers

- [Akbar J. Zaidi](https://www.globalkeysolutions.net/people/akbar-j-zaidi/9cd9ac91-2d4b-4f6f-a975-865342075924)

Company: https://www.globalkeysolutions.net/companies/glpgcp-development-asia-pte-ltd/1f245fd5-d660-4d72-8019-5e993c078d9e

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd