Enterprises should complete the rectification of all defects and the provincial bureau after the inspection qualified to resume production. The National Drug Administration Bureau ordered 4 Medical ma
Medical Network October 12 October 11 Night, the National Drug Administration official website issued a flight inspection bulletin, 4 of the enterprises are flying inspection in the inspection of serious defects, all production and rectification.
According to the advisory, 4 companies are flying inspection of the company is the Zhengzhou Dior Medical Technology Co., Ltd., Nanchang Wei material Medical Equipment Co., Ltd., Guangdong Lily Medical Technology Co., Ltd., Anhui Aerospace Biotechnology Co., Ltd.
In addition to the Nanchang Eisai Medical Equipment Co., Ltd. ' due to inspection ', the other three are GMP ' compliance check '.
On-site inspection is found in Nanchang Wei material Medical Equipment Co., Ltd. a total of 5 serious defects, including:
The original and auxiliary materials into the factory general ledger and Storage list shows the batch number of 0801 PP, polystyrene, can not be traced back to the original manufacturer batch number.
On-site inspection when the injection workshop is the expansion of the production of the upper and lower leaves, assembly and packaging, temporary storage of semi-finished goods, unpackaged and packaged products are no production records, process flow card filling the production date is June 2, 2018 (check the warehouse, all disposable sterile vaginal expander The Outer packing box shows that the production date is June 2, 2018); The final finished product quantity in all production records is consistent with the quantity of product before sampling inspection; <已灭菌和未灭菌>Ethylene oxide sterilization production record, no record of sterilization process, no record sterilization cabinet equipment number, dosing time, sterilization (heat preservation) time, sterilization completion time, vacuum number and other parameters, no operator, the person in charge of the signature.
Batch 20170214 One-time use sterile vaginal expander test report in the ' sterile (biological bacteria tablets) test records ' show, the use of bacterial tablet test method to test the sterile project, and the test basis yzb/gan 2327-2013 "disposable sterile vaginal expander" sterile test method inconsistent.
Clean area of the injection molding between the air purification system, clean room and the external pressure difference meter shows that the static pressure difference is zero, to thin tissue test back to the tuyere without any return wind reaction. 2017 Ethylene Oxide Sterilization Verification report (WC/QR-11-02), the ' tank wall temperature uniformity test ', ' sterilization device no-load space temperature uniformity test ', ' autoclave load after the chamber temperature uniformity test ' record shows ' heating start time ', ' reached set temperature time ' year are
2011.
In addition, on-site flight inspection found that the Zhengzhou Dior Medical Technology Co., Ltd. there are 3 serious defects:
The test method of ethylene oxide residue is formulated by the enterprise, and the standard curve of 6 concentrations of 1ΜG/ML-10ΜG/ML should be prepared separately after testing, but the examination finds that:
1. Sterilization date is August 3, 2018 the ethylene oxide residue of a batch product is only formulated 5 concentration standard curve;
2. Sterilization date for the April 28, 2018 production of a batch product of ethylene oxide residue test, the standard curve used in enterprise preparation solution concentration of 1μg/ml-40μg/ml.
The sterilization date is April 28, 2018 the standard curve data in the test record of ethylene oxide residue of a batch product can not be traced in the gas chromatograph used in the enterprise, and the test data of ethylene oxide residue of the batch product shown in the record is inconsistent with the data displayed in the gas chromatograph. Building 1th, the four-floor extrusion workshop and packaging workshop (all 100,000-level clean area) each one with a latch-off can be opened freely open about 1250pxx1250px window, open can be directly connected with the outside.
At the same time, the packaging room contains three diameter of about 125px pipe hole, direct access to the outside, no sealing measures, and two workshop doors are deformed cannot be closed.
Traceability requirements in the traceability control procedure for products are specified according to the uniqueness of the product, and the records can be traced back to the original Accessories The use of. Check the production record of Holmium (HO:YAG) laser treatment machine for medical use and the material inspection, release form,Purchase Material inspection records can not be traced back to the key components of the Holmium rod serial number.
Medical Holmium (HO:YAG) laser treatment machine finished product inspection report (Report No. 006) in the ' core diameter, length ', ' fiber transmission efficiency ', ' optical fiber transmission efficiency instability ' test results are ' in compliance ', but the corresponding test records do not have actual detection data.
Guangdong Lily Medical Technology Co., Ltd. there is a serious flaw: The first packaging equipment at the beginning of the million-class packaging plant directly under the 100,000-level packaging workshop, no protection measures, not effectively closed, there is no reasonable pressure gradient;
Million class, class 100,000 workshop each have a door to enter the initial packaging workshop, there are nearly 25px gap, and not latching, not set the differential pressure table, nor set a reasonable pressure gradient.
According to the advisory, the SFDA has instructed the local Food and Drug Administration to order the above-mentioned enterprises to immediately stop the rectification, in violation of theMedical devices Regulations on supervision and administration and related laws Regulations shall be dealt with in strict accordance with the law and require Enterprise To evaluate product safety risks and to recall related products in accordance with the provisions of the medical device recall management measures for potential safety hazards. The rectification of enterprise production and the supervision measures taken by the Provincial Bureau shall be published on the provincial bureau's website in time.
Enterprises should complete the rectification of all defects and the provincial bureau after the inspection qualified to resume production. The National Drug Administration Bureau ordered 4 Medical machinery Company ALL discontinued!
