Medical network on 3 January - December 30, Shanghai municipal food and drug administration announced that the agency recently organized six medical equipment manufacturing enterprises for the flight check, the results of the three was ordered to make correction, 1 cancellation according to law, two in the shutdown state.
A public announcement on December 27, sichuan food and drug administration, the bureau of chengdu on November 14 solstice 16 1 flight inspections on medical device manufacturing enterprise, the enterprise quality management system, there are serious defects was ordered to close immediately corrected.
The following details for seven companies were flying checks:
1, Shanghai fei jie industrial co., LTD., rectification within a time limit
Spot checks found that:
Shanghai fei jie industrial co., LTD. Has not provide parking again after open air purification system test validation information, can't provide clear downtime and boot record;
Enterprise process water preparation system is not used, to switch to outsourcing of drinking water, but did not provide the relevant verification record;
The required cleaning at the end of the production work instruction using 99% alcohol, purified water, but the enterprise actual use of 95% plus or minus 5% alcohol;
Assembly in a batch production records, cleaning cleaning, packing sealing, jaw grinding, check have different people to operate completion, production records made by the same person;
The scene saw that part of the batch production records without production batch number and production date, etc;
Companies outside the factory test equipment calibration period issued by the inspection report.
The disposal of:
Shanghai municipal food and drug administration to market regulatory bureau shall be ordered to make correction, and the cases suspected of illegal behavior investigation.
2, Shanghai yuan hong medical equipment co., LTD., rectification within a time limit
Spot checks found that:
Shanghai yuan hong medical instrument co., LTD. Clean areas and clean range differential pressure gauge shows zero, air purification system is not normally open, but companies are still in the packaging and line pressing workshop production of sterile medical devices;
Not according to enterprises "purification workshop purification equipment management regulations" regulation, in before using again for a week or more after discontinuation, in accordance with YY0033 "sterile medical appliances manufacturing management specification" requirements to carry out the whole project detection;
The clean room (area) the environmental monitoring record did not record in bacteria inspection room and asepsis room best grade purification units, wind, dust particle bacteria detection data;
On September 1, 2016-31 clean areas than YY0033 humidity monitoring and recording the sterile medical appliances production management norms "regulation, the enterprise is not in accordance with the production data analysis system of the purification workshop requirements for corrective measures;
Enterprise is unable to provide the factory inspection project entrusted inspection unit of qualification (water content test).
The disposal of:
Shanghai municipal food and drug administration to market regulatory bureau shall be ordered to make correction, and the cases suspected of illegal behavior investigation.
3, Lin of Shanghai medical equipment co., LTD., rectification within a time limit
Spot checks found that:
Lin of Shanghai medical instrument co., LTD. Clean the area on the ground and equipment have more dust, grease and sundry, raw material plastic particles exposure, stateless logo part transfer barrels, finished goods piled up in the office and toilet the corridor between the problem of quality.
The disposal of:
Shanghai municipal food and drug administration to market regulatory bureau shall be ordered to make correction, control the quality of risk.
(4), hisin medical biological material co., LTD., the cancellation
Spot checks found that:
Hisin on the medical biological material co., LTD. Has moved from the original production address.
The disposal of:
By local market regulator research confirmation, cancellation in accordance with the law.
5, ritual and medical equipment co., LTD., Shanghai to suspend production
Spot checks found that:
Shanghai ritual and medical equipment co., LTD in the shutdown state.
The disposal of:
Before resuming production shall, in accordance with the "measures for the supervision and administration of production of medical equipment rules written report local market regulator, the inspection qualified rear can resume production.
6, Shanghai secco orthopaedic equipment co., LTD., production
Spot checks found that:
Shanghai best orthopedic equipment co., LTD in the shutdown state.
The disposal of:
Before resuming production shall, in accordance with the "measures for the supervision and administration of production of medical equipment rules written report local market regulator, the inspection qualified rear can resume production.
7, chengdu Kang Fu scientific instrument co., LTD., production improvement
On-site inspection, found that the enterprise the following behavior does not conform to the YiXie GMP requirements, quality management system mainly exist the following defects:
Management representative to maintain the quality management system of the quality policy and quality objectives are not familiar with;
Equipment of the same device credit card number: there are two different equipment are: Q006 and PR013, inconsistent with equipment list;
Part of the production equipment is not timely calibration, field could not provide calibration report;
The enterprise has revoked the file not to cancel the invalid.
Product technical requirements for the establishment of the enterprise has not yet been determined, verification, confirmation and measurement devices required for the production of process activities;
The enterprise warehouse store four barrels of distilled water is not in accordance with the requirements in the product packaging production date, manufacturer, address shown on the basic information, such as purchasing goods do not conform to the requirements of the production;
Supplier qualification collection is not complete, supplier audit evaluation system construction is not perfect;
Part of the procurement records and incoming inspection report can not completely corresponding;
The name of the enterprise LingLiao District stored as "kraft rapidly by the sealant" (batch number: 15110405189; number: 2 box; production date: on November 4, 2015; expiration date: on November 4, 2016) for expired raw materials;
The production process, the part raw material is not classified depositing, mixture of risk;
The enterprise is not required to carry out medical device adverse event monitoring and evaluation, no adverse events monitoring record, in the state food and drug supervision administration of adverse drug reactions monitoring system in the no operation record;
The enterprise to customer feedback is not related to the quality of collection, statistics, analysis, and did not keep records of the results of data analysis.
The disposal of:
Chengdu food and drug administration shall order the enterprise to close immediately corrective, 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 the food and drug administration requirements of chengdu this enterprise product safety risk assessment, may lead to potential safety hazard, recall related products. |
