# China NMPA Inspection - Chongqing Nantong Contraceptive Device Factory Co., Ltd. - July 25, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/chongqing-nantong-contraceptive-device-factory-co-ltd/89d383ee-c0b4-4b4b-ac00-6e97e65fef48/
Source feed: China

> China NMPA unannounced inspection for Chongqing Nantong Contraceptive Device Factory Co., Ltd. published July 25, 2017. On July 4, 2017, an unannounced inspection was conducted at Chongqing Nantong Contraceptive Device Factory Co., Ltd., which produces copper-containing

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Chongqing Nantong Contraceptive Device Factory Co., Ltd.
- Company Name: Chongqing Nantong Contraceptive Device Factory Co., Ltd.
- Publication Date: 2017-07-25
- Product Type: Device
- Summary: On July 4, 2017, an unannounced inspection was conducted at Chongqing Nantong Contraceptive Device Factory Co., Ltd., which produces copper-containing intrauterine devices. The inspection, based on *Good Manufacturing Practice for Medical Devices* and its appendix for implantable devices, revealed significant non-compliance. The company had been in a state of prolonged production suspension since July 26, 2016, initially reporting a one-month shutdown for equipment upgrades. 

During the inspection, only two staff members were present. There were no traces of recent production, and no raw materials, packaging materials, or finished products were found on site. Critically, no quality management system documents or records were available, and access to the raw material warehouse, finished product warehouse, and testing laboratory was denied. Local authorities had previously identified this ongoing suspension during routine inspections in early 2017.

The main issues centered on the unauthorized and extended production halt, coupled with a complete lack of accessible quality management documentation and facilities. Chongqing Nantong Contraceptive Device Factory Co., Ltd. is required to immediately submit a formal production suspension report. Before any resumption of production, the company must provide a written report to the Chongqing Municipal Food and Drug Administration, with production contingent upon verification and approval by the municipal bureau. The municipal bureau must then report this resumption to the State Administration for Market Regulation. Local regulatory bodies were also tasked with monitoring the company's inventory to prevent non-compliant products from entering the market.

Company: https://www.globalkeysolutions.net/companies/chongqing-nantong-contraceptive-device-factory-co-ltd/cd43c343-6d90-42ed-a8ba-8f889c629611/