# FDA 483 - Lepu Medical Technology (Beijing) Co., Ltd. - November 23, 2023

Source: https://www.keypedia.com/records/483/lepu-medical-technology-beijing-co-ltd/f71c8f4a-ed3f-45be-8d25-030753231d67

> FDA 483 for Lepu Medical Technology (Beijing) Co., Ltd. on November 23, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lepu Medical Technology (Beijing) Co., Ltd.
- Inspection Date: 2023-11-23
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Lepu Medical Technology (Beijing) Co., Ltd. was cited for significant quality system deficiencies during an FDA inspection. The firm failed to establish adequate corrective and preventive actions for unauthorized shipments of SARS-CoV-2 rapid test kits to the U.S., leading to a Class 1 recall. Additionally, the inspection revealed a lack of design validation for their Shoocin Introducer Kits and inadequate device history records for these products.

## Related Officers

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

Company: https://www.keypedia.com/companies/lepu-medical-technology-beijing-co-ltd/e2b0350f-fc33-49c5-8fe6-6f7bffb037eb

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