# China NMPA Inspection - Chengdu Kangfu Scientific Instruments Co., Ltd. - May 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/chengdu-kangfu-scientific-instruments-co-ltd/664c23ea-5b27-43ca-918a-6e6076f1fd9d/
Source feed: China

> China NMPA unannounced inspection for Chengdu Kangfu Scientific Instruments Co., Ltd. published May 09, 2018. An unannounced inspection of Chengdu Kangfu Scientific Instruments Co., Ltd. was conducted by the National Medical Products Administration (NMPA) from

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Chengdu Kangfu Scientific Instruments Co., Ltd.
- Company Name: Chengdu Kangfu Scientific Instruments Co., Ltd.
- Publication Date: 2018-05-09
- Product Type: Device
- Summary: An unannounced inspection of Chengdu Kangfu Scientific Instruments Co., Ltd. was conducted by the National Medical Products Administration (NMPA) from April 17-18, 2018. The inspection, based on the Good Manufacturing Practice for Medical Devices, identified several key deficiencies in the company's manufacturing and quality control processes. Main violations included a shared and cramped warehouse for various materials, a lack of status indicators on production equipment, and facility maintenance records missing required handwritten signatures. The company also failed to adequately review production process specifications and safety assessments for purchased items, particularly Category A raw materials, and did not retain corresponding inspection reports. During production, treatment heads were found unlabeled, and measuring instruments like electronic balances and vernier calipers lacked proper internal calibration records, providing only external certificates. Furthermore, original inspection records were incomplete, and customer training on product use, though intended for distributors, was not explicitly detailed in contracts, hindering after-sales service traceability. In response, the Sichuan Provincial Food and Drug Administration has mandated that Chengdu Kangfu rectify these issues promptly, assess product safety risks, and initiate product recalls if safety hazards are identified. Follow-up inspections may occur, and the company must report its rectification progress to the NMPA.

Company: https://www.globalkeysolutions.net/companies/chengdu-kangfu-scientific-instruments-co-ltd/32c0a5dc-93b3-44da-b1fb-c30cbd0cfc22/