# China NMPA Inspection - Anhui Baojianlai Medical Equipment Trading Co., Ltd. - January 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/anhui-baojianlai-medical-equipment-trading-co-ltd/c49eb4a8-8e1a-4c53-a3b9-e73caf3e7628/
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> China NMPA unannounced inspection for Anhui Baojianlai Medical Equipment Trading Co., Ltd. published January 09, 2018. An unannounced inspection conducted from November 20th to 21st, 2017, at Anhui Baojianlai Medical Equipment Trading Co., Ltd. aimed to assess complian

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Anhui Baojianlai Medical Equipment Trading Co., Ltd.
- Company Name: Anhui Baojianlai Medical Equipment Trading Co., Ltd.
- Publication Date: 2018-01-09
- Product Type: Device
- Summary: An unannounced inspection conducted from November 20th to 21st, 2017, at Anhui Baojianlai Medical Equipment Trading Co., Ltd. aimed to assess compliance with the Good Manufacturing Practice for Medical Devices. The inspection uncovered eight deficiencies, comprising four critical and four general issues, highlighting significant gaps in the company's quality management system.

Major violations included the absence of complete training plans, records, and assessments for 2016 and 2017. The company's computer quality information management system was found to have incomplete transaction data, failing to trace specific purchase and sales records for critical medical devices like "Heparin Caps for Infusion" and "BD Indwelling Needles." Furthermore, critical supplier documentation, such as official seals on product registration certificates and supplier sales personnel identification, was missing. The company also failed to establish formal purchase contracts and after-sales service agreements for these transactions. Both inbound delivery slips from suppliers and outbound delivery slips for products sold by Anhui Baojianlai lacked essential regulatory information, including product registration numbers and complete purchaser details. Additionally, proper on-site acceptance records for incoming products were not maintained.

Under the "Regulations on the Supervision and Administration of Medical Devices," the Anhui Provincial Food and Drug Administration was instructed to order Anhui Baojianlai Medical Equipment Trading Co., Ltd. to rectify these issues within a specified period, conduct follow-up inspections, and report the remediation status to the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/anhui-baojianlai-medical-equipment-trading-co-ltd/6f2a576e-37fd-43b6-addd-f84c195c1e1f/