# FDA 483 - Unimicro Medical Systems (Shenzhen) Co., Ltd. - September 26, 2021

Source: https://www.globalkeysolutions.net/records/483/unimicro-medical-systems-shenzhen-co-ltd/ba9ada39-a534-46ca-9e86-6df7baa961d6

> FDA 483 for Unimicro Medical Systems (Shenzhen) Co., Ltd. on September 26, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unimicro Medical Systems (Shenzhen) Co., Ltd.
- Inspection Date: 2021-09-26
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Unimicro Medical Systems (Shenzhen) Co., Ltd. received a Form FDA 483 with 10 observations following an inspection of their medical device manufacturing facility. The inspection revealed significant deficiencies across various quality system areas, including design control, device master records, process validation, and corrective and preventive actions. These issues indicate a systemic lack of established and maintained procedures for critical manufacturing and quality processes for their Class II sterile Veress Pneumoperitoneum Needles.

## Related Officers

- [Felix J. Marrero](https://www.globalkeysolutions.net/people/felix-j-marrero/fe3bf64e-987b-40d9-8a17-754d58e13433)

Company: https://www.globalkeysolutions.net/companies/unimicro-medical-systems-shenzhen-co-ltd/21c0703f-383f-449c-8a6d-53c7e9f63b32

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