# FDA 483 - GPC Medical Ltd. - June 22, 2017

Source: https://www.keypedia.com/records/483/gpc-medical-ltd/3edbcfb2-ce77-4e0f-88d5-6ac07164d67f

> FDA 483 for GPC Medical Ltd. on June 22, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GPC Medical Ltd.
- Inspection Date: 2017-06-22
- Product Type: device
- 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, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm was cited for inadequate procedures related to labeling control, process validation, in-process product acceptance and control, and finished device acceptance. These issues indicate a lack of robust documentation and control over critical manufacturing processes.

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## Related Officers

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Company: https://www.keypedia.com/companies/gpc-medical-ltd/a667acd0-d288-4c53-9f7d-76fcd15fb830

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