Medical network - on November 24, 2016 in October, the administration of state food and drug supervision and administration organization of chengdu constant wave for flight check medical instrument co., LTD., found that the enterprise quality management system is mainly the following defects:
A, equipment
Not equipped with product registration standards required by the standing wave ratio, while the use of other equipment instead of standing wave ratio meter for radiator standing wave ratio test, does not conform to the medical device production quality management norms "and the relevant appendices (hereinafter referred to as the" specification ") in the enterprise should be equipped with corresponding to product inspection requirements of testing instruments and equipment requirements.
Second, the design and development
This enterprise on January 24, 2016 for product design change and implementation, but the relevant process documents on June 1, 2016 to make the change, on September 2, to implement a design change again, but not yet change corresponding process documents, is not in conformity with the "specification" of the enterprise shall give recognition to design and development changes and maintain records, when necessary, shall be for the design and development changes review, verification and validation, and approved before implementation.
Three, the production management
Spot check the products, its main components in the production process card uncertain raw material batch number that is not in conformity with the "norm" in each batch (Taiwan) products shall be production records, and satisfy the requirement of traceability.
Fourth, quality control
(a) products factory inspection specification of leakage current test code requirements and product registration standards specified in the wet pretreatment was carried out on the leakage current before and after wet pretreatment of inspection requirements, does not conform to the enterprise shall, according to "code for the mandatory standards and technical requirements set by a certified or registered products inspection code requirements.
(2) the actual product release approval person and enterprise departments and personnel responsibilities and authorities in the quality manual clearly do not match the personnel responsible for product release audit, does not conform to the enterprise shall stipulate in the code for the product release process, conditions and release approval requirements.
The enterprise has to confirm this. The enterprise behavior mentioned above does not comply with the regulations relevant provision, production quality management system, there are serious defects administration of state food and drug supervision and administration of instruct sichuan province food and drug administration shall be ordered to the enterprise to close immediately corrective and involving in violation of the regulations on the supervision and administration of medical devices and related laws and regulations, in accordance with the law, serious processing. While sichuan province food and drug administration requires that the enterprise product safety risk assessment, could lead to potential safety problems, should be in accordance with the "measures for the management of medical device recall (try out)" (the original health ministry make 82) regulation, a recall of related products.
For all enterprises to complete the project rectification and approved by sichuan provincial food and drug administration track review qualified rear can resume production.
Please take note.
The food and drug supervision bureau
On November 16, 2016
Medical health pigeons on the Shanghai medical equipment co., LTD flight check
Shanghai medical kang pigeon on medical equipment co., LTD. Of the following actions (see table) is not in conformity with the quality management for medical equipment production specification requirements, quality management system defects. At present, the enterprise has been shut down, and the sterilization parameters change after sterilization batch product recall, to carry out the sterilization validation. The enterprise to resume production before written report shall be in accordance with the relevant regulations of Shanghai food and drug administration, the Shanghai municipal food and drug administration inspection qualified rear can resume production. |
