# FDA 483 - Ningbo Besmed Medical Equipment Corp. - May 15, 2025

Source: https://www.globalkeysolutions.net/records/483/ningbo-besmed-medical-equipment-corp/afc4b413-5837-4487-a0d8-5d30f9c5514a

> FDA 483 for Ningbo Besmed Medical Equipment Corp. on May 15, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Ningbo Besmed Medical Equipment Corp.
- Inspection Date: 2025-05-15
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Ningbo Besmed Medical Equipment Corp. in Ningbo, China, revealed significant deficiencies across its quality system for medical device manufacturing, particularly concerning disposable nebulizer sets. The firm failed to establish adequate procedures for complaint handling, non-conforming product control, finished device acceptance, process controls, incoming product acceptance, labeling, and Medical Device Reporting. Additionally, device history records were incomplete, and product contamination prevention procedures were lacking, indicating systemic issues in maintaining product quality and regulatory compliance.

## Related Documents

- [483 - 2019-06-12](https://www.globalkeysolutions.net/records/483/ningbo-besmed-medical-equipment-corp/79171138-174d-496c-bb88-a2e4d9b1c689)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/ningbo-besmed-medical-equipment-corp/0ff7e6cf-73c6-4e5a-9281-34595025cbf6

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8