# FDA 483 - Vega Technologies Inc. - November 10, 2023

Source: https://www.keypedia.com/records/483/vega-technologies-inc/4be36b3e-d5f0-46f2-8b8b-95e0e6bca179

> FDA 483 for Vega Technologies Inc. on November 10, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vega Technologies Inc.
- Inspection Date: 2023-11-10
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Vega Technologies Inc., a medical device manufacturer in Dongguan, China, revealed significant deficiencies in its quality system. Observations included inadequate procedures for design validation, complaint handling, process controls, and device history records for their Medical Suction Equipment. The firm also lacked developed written Medical Device Reporting (MDR) procedures.

## Related Officers

- [Thai T. Duong](https://www.keypedia.com/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.keypedia.com/companies/vega-technologies-inc/e762dcce-adc8-481b-b21c-89cda8b0d6c5

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