# China NMPA Inspection - Shanghai Lubi International Trade Co., Ltd. - January 10, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/shanghai-lubi-international-trade-co-ltd/bd314045-142c-46b9-802f-0fc38481f6eb/
Source feed: China

> China NMPA unannounced inspection for Shanghai Lubi International Trade Co., Ltd. published January 10, 2018. Shanghai Lubi International Trade Co., Ltd. was subject to an unannounced compliance inspection from November 22-23, 2017. The inspection, conducted u

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Surprise Inspection of Shanghai Lubi International Trade Co., Ltd.
- Company Name: Shanghai Lubi International Trade Co., Ltd.
- Publication Date: 2018-01-10
- Product Type: Device
- Summary: Shanghai Lubi International Trade Co., Ltd. was subject to an unannounced compliance inspection from November 22-23, 2017. The inspection, conducted under the *Good Manufacturing Practice for Medical Devices*, identified a total of 10 deficiencies, comprising one critical and nine general issues. The critical finding involved a pneumatic sandblasting dental handpiece whose Chinese label displayed structural composition information inconsistent with its approved product registration certificate. General violations included significant shortcomings in personnel management, such as the absence of key roles like acceptance, receiving, and purchasing personnel from the enterprise roster, along with a lack of training for these critical positions. The company also failed to conduct annual health checks for staff directly handling medical devices. Facility-related issues noted were the absence of insect and rodent control in the warehouse and uncalibrated temperature and humidity monitoring equipment. Operational failures included incomplete daily temperature and humidity records, particularly on weekends; inadequate inspection of product labels; and deficiencies in managing sales authorization letters, outbound product verification, and the processing of returned goods. As a result, the Shanghai Municipal Food and Drug Administration is required to direct the company to promptly rectify all identified issues, conduct follow-up inspections, and report the completion of these corrective actions to the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/shanghai-lubi-international-trade-co-ltd/eb51eb8f-78b6-4782-a473-4e1d36e0bfad/