# FDA 483 - GLPGCP Development (Asia) Pte. Ltd. - June 22, 2017

Source: https://www.globalkeysolutions.net/records/483/glpgcp-development-asia-pte-ltd/8bad919d-c1b6-4fee-b805-fadc9ef0faa4

> FDA 483 for GLPGCP Development (Asia) Pte. Ltd. on June 22, 2017. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GLPGCP Development (Asia) Pte. Ltd.
- Inspection Date: 2017-06-22
- Product Type: other
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of GPC Medical Ltd. in New Delhi, India, revealed significant deficiencies in their quality system for device manufacturing. The firm was cited for inadequate procedures concerning labeling activities, process validation, and the acceptance and control of both in-process and finished devices. These observations highlight a need for comprehensive improvements in their operational controls.

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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