# FDA 483 - SAFE Medical Technology Co., LtD. - May 12, 2025

Source: https://www.globalkeysolutions.net/records/483/safe-medical-technology-co-ltd/c7dc38ab-1b50-4937-9ef8-f7fab06240f8

> FDA 483 for SAFE Medical Technology Co., LtD. on May 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SAFE Medical Technology Co., LtD.
- Inspection Date: 2025-05-12
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: The FDA inspected Safe Medical Technology Co., Ltd., a nonclinical laboratory in Gu'an, China, and issued a Form 483 with nine observations. Deficiencies were noted across quality assurance, data integrity, record keeping, facility maintenance, and personnel training. These issues highlight a systemic failure to adhere to established protocols and maintain adequate documentation for nonclinical studies.

## Related Officers

- [Mark Sexton](https://www.globalkeysolutions.net/people/mark-sexton/c0214765-12d1-4a6b-9d9e-5ad41ed07cc7)
- [issuing_officer](https://www.globalkeysolutions.net/people/zhou-chen/03362438-eba1-4010-b6b1-5cccf25a824c)
- [investigator](https://www.globalkeysolutions.net/people/hugh-mcclure-iii/e7c5254e-39e9-47d4-afa0-cab9480ef6fe)

Company: https://www.globalkeysolutions.net/companies/safe-medical-technology-co-ltd/0dcf5281-296c-4166-8c55-9d91e6ab5980

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4