The State Drug Administration on the flight inspection of Sichuan Bai Amon Biological Activation Materials Co., Ltd.

The State Drug Administration on the flight inspection of Sichuan Bai Amon Biological Activation Materials Co., Ltd.

(No. 34, 2022)

Recently, the State Drug Administration organized an inspection team to conduct a flight inspection on Sichuan Bye Meng Biological Active Materials Co., Ltd. The inspection found that the company's quality management system mainly exists in the following defects:

1. Institutions and personnel, facilities and facilities and equipment

Enterprises are located on the production site A in Wangjiang Road, Chengdu City and the production site B of the Xixin Avenue of Chengdu High -tech Zone. On -site inspections found that the production venues, institutions and personnel, production and inspection equipment of Area B belonged to another related company. Documents such as equipment operation procedures, operation guidance documents, etc. in the production site B are formulated by related companies. There are two different versions of the program files and institutional documents of the enterprise in areas of A and B. The method of the device purifies the air, and uses a small mobile ozone generator to disinfect the indoor environment. The above does not comply with the "Regulations on the Management of Quality Management of Medical Device Production" and "Material Management Specifications for the Management of Medical Device Production Quality Management" (hereinafter referred to as the "Specification") in the following requirements: First, the enterprise shall be equipped with professional technologies that are compatible with production products. Personnel, managers and operators have corresponding quality inspection agencies or full -time inspectors; second, enterprises should be equipped with inspection venues and facilities that are suitable for product production scale, varieties, and inspection requirements; Matching production equipment, process equipment, etc., and ensure effective operation.

2. Procurement management

Enterprises have not signed a quality agreement with Class B and C material suppliers. The procurement control procedure does not clarify whether the quality agreement is signed by different categories of materials. The enterprise in the "Specification" should sign the quality agreement with the main raw material suppliers to clarify the two parties. Requirements for quality liability.

3. Production management

Enterprises fail to provide sterilization confirmation reports. The sterilization process in the "Standards" shall be confirmed before the initial implementation of the relevant standards, and then confirmed before necessary, and maintains the requirements for confirmation records of the sterilization process.

There are serious defects in the quality management system of the enterprise, which does not meet the relevant provisions of the "Regulations for the Management of Medical Device Production Quality Management" and "Medical Device Production Quality Management Specifications". The company has confirmed the above defects of its quality management system.

The Sichuan Provincial Drug Administration shall, in accordance with Article 72 of the Regulations on the Supervision and Administration of Medical Devices, shall take control measures to suspend production in accordance with the law in accordance with the law. ; And ordered the company to evaluate the safety risk of product safety. For those who may cause hidden dangers, they will recall related products in accordance with the "Administrative Measures for Medical Device Recall".

The enterprise has completed all project rectifications and has been represented by the Sichuan Provincial Drug Administration for review.

announce.

State Drug Administration

July 18, 2022

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