The State Drug Administration raided four arms companies and stopped production.

On October 20, the State Drug Administration issued a notice on the flight inspection of four enterprises, including Qinghai Densta Medical Devices Co., Ltd., and found that the enterprise quality management system was mainly flawed, mainly related to institutions and personnel, production management, quality control, adverse event monitoring, analysis and improvement, equipment, design and development.
State Drug Administration said that the quality management system of four enterprises is seriously flawed and does not comply with the relevant regulations of the quality management norms for the production of medical devices.
enterprises have confirmed the defects of the above-mentioned quality management system.
The State Drug Administration has ordered the four enterprises mentioned above to stop production and rectification immediately in accordance with the law, and to deal seriously with those involved in violation of the Regulations on The Supervision and Administration of Medical Devices and related laws and regulations;
enterprises to complete all project rectification and by the territory of the provincial drug regulatory authority to review qualified before the resumption of production.
provincial drug regulatory authority in the territory of china shall report the rectification of the enterprise to the State Drug Administration in a timely manner.
way to see the real thing by not hitting the public, not greeting, and going straight into the business.
is this way, so is flight inspection.
for the flight inspection, is mainly concerned about the production quality management system of enterprises, professional inspection team not far from thousands of miles to the enterprise's purpose is to point out the problem, urge enterprises to carry out continuous improvement of the production quality management system.
In the inspection mode, the inspection will take the way of not informed in advance, do not say hello, do not listen to the report, do not accompany the reception, go straight to the grass-roots level, directly plug in the scene, to find the outstanding problems and weak links existing in the enterprise.
58 key points, self-checking in the flight inspection has become normal, flight inspection what other key points? Below is a summary of the flight inspection terms compiled from public data collection for reference.
six major inspection points of medical devices (38 sub-projects) (i) Finance Department 1, payment accounts - to the public payment account.
2, payment vouchers - relevant personnel signed for approval.
3, account classification - monthly printing account categories (receivables, payables, balances).
4, the tax ticket and the accompanying document amount is the same.
5, with the goods peer document variety details and tax list varieties, the amount is consistent.
6, check the salary scale - pay the salary record details.
(2) Administrative Department 7, check the roster of employees - personnel education.
8, training files - annual training plan, training papers, training courseware.
(iii) Procurement Department 9, supplier qualifications - licenses, GSPs, account opening banks, business licenses, general taxpayer qualifications, scope of entrustment, commission time, entrustment area.
10, suppliers with the goods peer list - color, document content, document fresh chapter style.
11, seal filing and the most recent purchase of bills check.
12, account opening license and transfer account number and tax ticket account number.
13, supply units - business scope (procurement site operation system to do procurement planning: check the scope, the system can be controlled).
(4) Sales Department 14, downstream customer information - medical institutions license, business license, power of attorney, copy of the principal's identity card, entrustment time (all stamped with fresh seal).
15, containing special drug mouth compound preparation (egg peptide) receipt ---sa delivery man, shipper, reviewer, delivery to the conseor, time."
16, cold chain drugs - transportation records, handover records, self-collection records, handover receipts (receipt document content - supplier unit, purchase unit, purchase time, shipping time, shipping temperature, delivery temperature, quantity of drugs purchased, amount, manufacturer, approval number, transporter, reviewer, salesman, ticket opener, purchase unit receipt signature, time, seal).
17, sales flow details--- including special drugs compounding Liu (compound licorice oral solution, aminophen cause, etc.) in recent months a large number of single purchases (20 bottles / box or more).
18, sales flow with details - termination (purchase unit - certificate "license" principal ID card copy, power of attorney).
(v) Quality Management Department 19, the company GSP documents - system, responsibilities, operating procedures.
20, drug quality files - the first camp variety files (the original electronic version of the document is not recognized).
21, the first enterprise - approval process (on-site exercise) random extraction of archival data.
22, acceptance - cold chain drug operation, inspection report, system operation process.
23, supplier file approval - approval form (relevant personnel system review, actual operation).
24, verification - cold car verification information, payment details, signed joint action, participate in the verification personnel.
25, verification - field operation.
26, cold car, insulation box - verification unit information, payment vouchers, taxes.
27, internal audit - special internal audit (signature, participants ask questions).
28, information administrator - ask questions (maintenance, use, set permissions, UPS) to assist in quality audit computer permission control (check permission management for vulnerabilities).
(6) The storage and transportation department 29, the drug classification --- the whole part of the cargo area (on the shelf).
30, treasury area - cool? At ambient temperature? 31, the total area of the reservoir area - shady library? M2 room temperature library? m2 Chinese medicine tablet bank? ㎡.
32, pharmaceutical stacking - mixing situation, spacing (off the wall, ground, pipe).
33, treasury equipment - temperature and humidity controller, dehumidifier, wind curtain machine, generator.
34, cold storage - use, drug classification stack code, cold chain drug receipt, acceptance, review, delivery.
35, insulation box - on-site drill operation box (questions).
36, drug storage conditions -- room temperature? Cool? 37, special management of drugs - storage management, receipt, acceptance, review, shipping operations.
38, cold chain drugs - receipt, acceptance, delivery, review, delivery site operation.
eight inspection key points (20 sub-projects) (i) quality management personnel 1, quality responsible for - hanging on (on-site system to take questions, ask wages).
(ii) Quality Management Department 2, the responsible person of the quality organization - hanging on (questions participated in the internal audit time, verification of participants, verification of the company's name).
(3) Finance 3, receivables, payables, balances (check whether there is any ticketing behavior).
4, employee salary scale - check and rely on the actual operation.
(4) special drug compound preparation 5, supplier information (business scope, tax tickets, vouchers, details).
6, purchase unit information A, cash purchase - check documents (signed by the corresponding principal).
B, check the 2015 purchase details - the purchase quantity is larger: re-check - qualification, sales notes, receipts.
7, extracted goods in the warehouse A, a batch of purchase quantity, sales quantity, inventory quantity.
B, provide details, corresponding batch with-shipment documents, tax tickets, transfer vouchers.
C, supplier information - business scope, account opening license number and transfer number and tax ticket account number is consistent.
D, inspection report, registered batch, drug quality file.
(v) Refrigeration 8, suppliers - data, modes of transport, means of transport, records (data, handover documents).
9, refrigeration emergency - how to deal with unexpected situations (car broken, insulation box temperature is too low too high, robbed, etc.).
10, on-site operation of refrigerated drug delivery drill.
11, on-site drill refrigeration drug delivery link (delivery operation, data how to buy units).
12, refrigerated drugs - delivery methods (test quality, transporter, salesman) how to choose both effective and quality of transport.
(vi) computer rights control - print paper files (corresponding to each person viewing system) 13, information administrator - feel free to modify the data (recorded?) Is there approval? 14, quality management department - how to review the authority of each post can effectively prevent non-overseer? A, suppliers - procurement (manager, in-house attendance; supplier business scope.
B, purchase customers (sales manager, salesman, sales Neller), business scope.
(seven) egg peptide drugs 15, insulin -- purchase, sale, inventory flow; upper house information, next home information; first batch of drug quality information, 16, special inspection of imported products - registration batch (first-time documents "first camp varieties" cardboard and system approval are seen) (eight) facilities equipment 17, verification - adventure head (how many), back-office operation management system (how to enter, how to operate, who can modify the data? )。
18, verification of participants - random sampling (see if there is fraud) verification time, participants.
19, verify all the information to inquire in detail.
20, check equipment purchase information, payment, and original tax tickets.
following is the details of the enterprises investigated on October 20: Qinghai Densta Medical Devices Co., Ltd. (I) institutions and personnel.
the quality of the company also served as fixed teeth production department, porcelain group, the head of the whole porcelain group, the manager's representative also served as the head of the production department, while responsible for product approval release work.
Does not comply with the Medical Device Production Quality Management Code (hereinafter referred to as the Code), the enterprise shall be equipped with professional and technical personnel, management personnel and operators suitable for the production of products, with the corresponding quality inspection institutions or full-time inspection personnel requirements.
(ii) production management.
not fully in accordance with the registered product technical requirements of the organization of production.
enterprises that do not comply with the Code shall produce in accordance with the established quality system to ensure that the products meet the mandatory standards and the technical requirements of the products registered or filed.
(iii) quality control.
Some of the inspection items and inspection methods specified in the factory inspection procedures for custom fixed and custom active teeth are not fully consistent with the technical requirements of the registered product and fail to provide the factory inspection report or certificate for the number A1000102 custom fixed righteous teeth.
enterprises that do not comply with the Code shall formulate inspection procedures for products in accordance with mandatory standards and the technical requirements of the products registered or filed, and issue the corresponding inspection reports or certificates.
The enterprise has not established the Product Release Procedure, claiming that the Finished Product Inspection Control Procedure is the product release procedure, but the program document does not specify the conditions for product release and release standards, does not specify the responsibilities of product release personnel, and does not meet the requirements of the Code that the enterprise shall prescribe the product release procedures, conditions and release approval.
monitoring, analysis and improvement of adverse events.
enterprises in this year's management review work is only carried out in accordance with ISO13485:2016, and the recorded registered testing content is inconsistent with the actual situation of the company, does not comply with the Code enterprises should regularly carry out management review, quality system evaluation and audit to ensure its continued suitability, adability and effectiveness requirements.
, Zhejiang Jinhua Monday Biotechnology Co., Ltd. (I) institutions and personnel.
production technicians and full-time inspection personnel have not carried out training appropriate to their job requirements, there is no training content and training records.
personnel who do not comply with the Code and engage in work affecting product quality shall be trained in accordance with the requirements of their posts and have relevant theoretical knowledge and practical skills.
(ii) quality control.
control room biosecurity cabinet has not been checked, has been bad not timely maintenance, sterile room ultra-clean work table has been bad not timely maintenance.
enterprises that do not comply with the Code and the Appendix of the Medical Device Production Quality Management Code for sterile medical devices shall have the testing capability of sterile, microbial limits and positive controls.
(iii) the monitoring, analysis and improvement of adverse events.
enterprises have not revised the system document in accordance with the newly released Measures for monitoring and re-evaluation of adverse medical device events.
enterprises that do not comply with the Code shall establish a monitoring system for adverse events of medical devices in accordance with the requirements of relevant regulations.
Shenzhen Haibo Technology Co., Ltd. (I) institutions and personnel.
the 3D Forming Radiotherapy Program System User Test Report to record developers participating in black box testing.
black box testing that does not comply with the Code and the Appendix Independent Software of the Medical Device Manufacturing Practice shall ensure that developers and testers of the same software item do not interact with each other.
(ii) equipment.
The maintenance of the software development test environment has not formed a document, there are no requirements for regular verification and update upgrades, and the software development and test environment maintenance that does not conform to the Code and the Appendix of the Medical Device Production Quality Management Code shall form a document to determine the requirements of the software development and test environment for regular verification, update and upgrade, virus protection and other activities, and maintain the relevant records.
(iii) design and development aspects.
software configuration management tool does not implement version control, the version naming rules in the configuration management control program file are not consistent with the technical requirements of the product.
Software version control that does not comply with the Code and the Appendix Independent Software of the Medical Device Manufacturing Practices shall determine the software version naming rules based on compliance requirements, covering all types of software, off-the-go software, and network security, and the meaning of each field shall be clear and without ambiguity.
software version changes should comply with the software version naming rules.
non-retroactive analysis control procedures, no relevant documents and tools.
Software traceability analysis that does not comply with the Code and the Appendix Independent Software of the Medical Device Manufacturing Practices shall establish control procedures and documentation covering the control requirements of off-the-go software and network security, and form a software traceability analysis report for review.
use traceability analysis tools to ensure that software development, software update process to meet traceability requirements, and throughout the software life cycle.
risk management-related content is missing from the software requirements specification and does not include traceability analysis activities.