# China NMPA Inspection - Jiangxi Teli Anesthesia and Respiratory Equipment Co., Ltd. - November 20, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangxi-teli-anesthesia-and-respiratory-equipment-co-ltd/1eefd55a-8518-4c90-9601-0affaf3beeaf/
Source feed: China

> China NMPA unannounced inspection for Jiangxi Teli Anesthesia and Respiratory Equipment Co., Ltd. published November 20, 2017. An unannounced inspection of Jiangxi Teli Anesthesia and Respiratory Equipment Co., Ltd. took place on November 7, 2017, to assess compliance with Goo

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Jiangxi Teli Anesthesia and Respiratory Equipment Co., Ltd.
- Company Name: Jiangxi Teli Anesthesia and Respiratory Equipment Co., Ltd.
- Publication Date: 2017-11-20
- Product Type: Device
- Summary: An unannounced inspection of Jiangxi Teli Anesthesia and Respiratory Equipment Co., Ltd. took place on November 7, 2017, to assess compliance with Good Manufacturing Practice for Medical Devices. The inspection revealed that the company had ceased operations since March 17, 2017. Furthermore, the registration certificate for its High-Frequency Jet Ventilator and its medical device production license had both expired on March 17, 2017, and June 12, 2017, respectively. The company cited delays in the release of new industry standards as the reason for not submitting timely renewal applications.

As a result, the Jiangxi Provincial Food and Drug Administration (FDA) is mandated to closely monitor Jiangxi Teli. The company is required to apply for the cancellation of its expired certificates. Any future intent to resume production necessitates reapplication for and obtaining new product registration and production licenses before operations can commence. The FDA will also oversee the quality and safety of products previously marketed by the company, holding Jiangxi Teli accountable for its primary quality and safety responsibilities during the validity period of those products.

Company: https://www.globalkeysolutions.net/companies/jiangxi-teli-anesthesia-and-respiratory-equipment-co-ltd/cd67b0fd-ca6f-4696-aabe-d6fadaf5530a/