# FDA WARNING_LETTER - Global Medical Production Co Ltd - July 30, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/global-medical-production-co-ltd/9f12ec48-4045-4917-a556-dc716c7c9afd

> FDA WARNING_LETTER for Global Medical Production Co Ltd on July 30, 2021. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Global Medical Production Co Ltd
- Inspection Date: 2021-07-30
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: The FDA issued a Warning Letter to a Chinese manufacturer of Sterile and Non-Sterile Electrosurgical Scissors, Sterile Electrosurgical Graspers, and Sterile Veress Pneumoperitoneum Needles following a July 2021 inspection. The inspection revealed that the devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to provide required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting).

Key violations include:
1.  **Failure to control device design (21 CFR 820.30(a)):** No design control procedures or documentation for private label devices for the US market. This is a repeat violation from 2015. The firm's response was inadequate as it lacked assessment of impact on distributed devices and evidence of implementation.
2.  **Failure to control nonconforming product (21 CFR 820.90(a)):** Procedures lacked requirements for evaluation, disposition, investigation, and notification for nonconforming products. The firm's response was inadequate, lacking assessment of risk from potential release of noncon

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/binita-s-ashar/5a2f78e1-1ad7-4bf2-b980-eb925e2c765e)
- [Mike Athey](https://www.globalkeysolutions.net/people/mike-athey/3956c33d-b928-4f76-98a2-a6c2e0f04360)

Company: https://www.globalkeysolutions.net/companies/global-medical-production-co-ltd/e662bee5-d1af-4da8-98d7-ee2a8e2549d0

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7