# FDA 483 - GPC MEDICAL LIMITED - October 21, 2019

Source: https://www.keypedia.com/records/483/gpc-medical-limited/2a88341a-89d4-4bd5-86b7-8e039a09a216

> FDA 483 for GPC MEDICAL LIMITED on October 21, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GPC MEDICAL LIMITED
- Inspection Date: 2019-10-21
- Product Type: device
- Office Name: Foreign - CBER (Bioresearch Monitoring)
- Summary: GPC MEDICAL LIMITED, a medical device manufacturer in Sonepat, India, was inspected by the FDA from October 21-24, 2019. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate process control procedures, insufficient in-process product acceptance protocols, and a lack of established corrective and preventive action procedures. Additionally, the firm failed to adequately validate critical processes and maintain equipment schedules, indicating a systemic breakdown in quality management.

## Related Officers

- [investigator](https://www.keypedia.com/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.keypedia.com/companies/gpc-medical-limited/57de9d3d-38b3-4ce8-a5fd-2452aada3cda

Office: https://www.keypedia.com/offices/foreign-cber-bioresearch-monitoring/f1660531-9111-4f36-bf5d-b28bf0f3b54e