# China NMPA Inspection - Guizhou Fenglei Aviation Ordnance Co., Ltd. - November 20, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/guizhou-fenglei-aviation-ordnance-co-ltd/8453b5db-5930-4f2b-ae76-a0dde4bc6fbf/
Source feed: China

> China NMPA unannounced inspection for Guizhou Fenglei Aviation Ordnance Co., Ltd. published November 20, 2017. An unannounced inspection of Guizhou Fenglei Aviation Ordnance Co., Ltd., conducted from November 8-9, 2017, by the NMPA (National Medical Products Ad

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## Details

- Record Type: CHINA_INSPECTION
- Title: Flight Inspection Report on Guizhou Fenglei Aviation Ordnance Co., Ltd.
- Company Name: Guizhou Fenglei Aviation Ordnance Co., Ltd.
- Publication Date: 2017-11-20
- Product Type: Device
- Summary: An unannounced inspection of Guizhou Fenglei Aviation Ordnance Co., Ltd., conducted from November 8-9, 2017, by the NMPA (National Medical Products Administration), identified 12 general deficiencies in their adherence to Good Manufacturing Practice for Medical Devices. The inspection focused on the company's Medical Oxygen Hydraulic Chamber product line. Key issues included a lack of usage records for welding equipment, expired calibration for a pressure gauge, and systemic failures in document control for operating procedures, including drafting, revision, distribution, and archiving. The company's design and development control procedures lacked requirements for design conversion, and critical design inputs for the medical oxygen booster chamber were missing industry standards and risk management measures. Further non-compliances involved inaccurate acceptance criteria for raw materials, unverified cleaning processes for oxygen supply pipes, and inadequate evaluation of welding parameters. Traceability was compromised by the absence of batch information on raw material storage cards. The inspection also found that inspection procedures did not differentiate between incoming, in-process, and finished product checks, and there was a failure to analyze product quality data or the root causes of non-conforming products. The Guizhou Provincial Food and Drug Administration ordered the company to rectify these issues within a specified timeframe, assess product safety risks, and recall any products posing hazards. Follow-up inspections are mandated, and the rectification progress must be reported to the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/guizhou-fenglei-aviation-ordnance-co-ltd/144a2dfd-22bd-418b-b995-deef78e6dbb1/