# FDA 483 - Ming Fai Industrial (Shenzhen) Co LTD - March 10, 2023

Source: https://www.keypedia.com/records/483/ming-fai-industrial-shenzhen-co-ltd/3f2c42d5-9f55-403f-b2af-9c3ce259c6aa

> FDA 483 for Ming Fai Industrial (Shenzhen) Co LTD on March 10, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ming Fai Industrial (Shenzhen) Co LTD
- Inspection Date: 2023-03-10
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Ming Fai Industrial (Shenzhen) Co. Ltd. in Shenzhen, China, received six observations during an FDA inspection from March 6-10, 2023. The inspection revealed significant deficiencies in the firm's quality system procedures for medical devices intended for the U.S. market. Key issues included inadequate complaint handling, lack of Medical Device Reporting procedures, insufficient process validation documentation, and poorly established design control, storage area control, and finished device acceptance procedures.

## Related Documents

- [483 - 2017-08-11](https://www.keypedia.com/records/483/ming-fai-industrial-shenzhen-co-ltd/d0e6a9b8-9a5a-4212-b61d-156a2b68e9c5)

## Related Officers

- [Janete F. Guardia](https://www.keypedia.com/people/janete-f-guardia/2405f83f-7ea9-4056-afbd-7d9c00a6e169)

Company: https://www.keypedia.com/companies/ming-fai-industrial-shenzhen-co-ltd/42a4f27f-197d-4ee5-b8e6-be51390d921a

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