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

Source: https://www.keypedia.com/records/483/lepu-medical-technology-beijing-co-ltd/04b8e5b4-7167-4c24-8e6b-0b5353d65754

> FDA 483 for Lepu Medical Technology (Beijing) Co., Ltd. on November 23, 2023. Product: devices. 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: devices
- Office Name: Office of Regulatory Affairs
- Summary: During an inspection conducted from November 20 to November 23, 2023, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Lepu Medical Technology (Beijing) Co., Ltd., a medical device manufacturer. The inspection revealed significant observations related to the company's quality management system, indicating potential non-compliance with medical device regulations.

Three primary issues were noted. First, the company's procedures for corrective and preventive actions (CAPA) were deemed inadequate. This was exemplified by the failure to establish a CAPA for the unauthorized shipment of SARS-CoV-2 test kits to the U.S., which led to a Class 1 recall. Second, deficiencies were found in the design validation procedures, specifically for the Class II Shoocin Introducer Kit, which lacked proper design validation despite being shipped to the U.S. since 2014. Third, the firm's device history records (DHRs) for the Shoocin Introducer Kits did not adequately demonstrate that devices were manufactured according to established procedures, lacking critical details such as primary identification labels and Unique Device Identifiers (UDIs).

These observations highlight the need for Lepu Medical Technology to enhance its quality system to ensure compliance with FDA requirements for medical device manufacturing. The company acknowledged these observations and promised to implement corrective actions. A comprehensive response outlining these actions is expected to address the deficiencies and prevent recurrence.

## Related Documents

- [483 - 2023-11-23](https://www.keypedia.com/records/483/lepu-medical-technology-beijing-co-ltd/f71c8f4a-ed3f-45be-8d25-030753231d67)

## 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/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64