# China NMPA Inspection - Shandong Baiduoan Medical Equipment Co., Ltd. - August 04, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/shandong-baiduoan-medical-equipment-co-ltd/02aafd96-a386-47db-af0c-8c4acdb5195f/
Source feed: China

> China NMPA unannounced inspection for Shandong Baiduoan Medical Equipment Co., Ltd. published August 04, 2017. An unannounced inspection of Shandong Baiduan Medical Device Co., Ltd. occurred on July 18-19, 2017, focusing on compliance for their Peripherally Tra

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Shandong Baiduan Medical Device Co., Ltd.
- Company Name: Shandong Baiduoan Medical Equipment Co., Ltd.
- Publication Date: 2017-08-04
- Product Type: Device
- Summary: An unannounced inspection of Shandong Baiduan Medical Device Co., Ltd. occurred on July 18-19, 2017, focusing on compliance for their Peripherally Transient Central Catheter Kit. Based on Good Manufacturing Practice for Medical Devices and its sterile medical device appendix, the inspection revealed numerous deficiencies. Main violations included an incomplete organizational chart, lack of daily maintenance procedures for purified water equipment, and inadequate documentation for changes in packaging material microbial testing. A significant issue was the failure to conduct risk assessments and validations when changing sterile packaging material production from external to in-house, potentially impacting product safety and effectiveness. Production batch records also lacked essential process parameters. Aseptic control issues included a pass-through window without air supply, improper ventilation in a new sanitary ware room, insufficient validation for compressed air used in drying, and incomplete material disinfection records. Sterilization process parameters in batch records were inconsistent with validation documentation. The Shandong Provincial Food and Drug Administration mandated the company rectify all identified problems, assess product safety risks, and recall any hazardous products. Follow-up inspections and reporting to the State Administration for Market Regulation are also required.

Company: https://www.globalkeysolutions.net/companies/shandong-baiduoan-medical-equipment-co-ltd/9fbcabff-5749-42d9-96ea-ac3409179b50/