The second batch of medical equipment manufacturers were ordered to halt production immediately after the second batch of results of the second batch of medical devices were released on April 27.
Based on drug safety administration of hair on the 26 April announcement, April 10-12 this year, Beijing, jiangsu, guangdong three lenses products production enterprise has a flight check.As a result, the three companies were found to have serious defects in the quality management system and violated the requirements of GMP.
Beijing natural beauty optics co., LTD. : stop production and check in accordance with law
Product name: soft wet contact lens
There are 7 serious defects, including the discrepancy between the sample test sample and the registered product standard.The inspection record cannot be traced;The technical requirements of some raw materials do not meet the requirements of the current Chinese pharmacopoeia;The process parameters of the critical process are not validated and confirmed;Non-conforming products are not identified and isolated.
At the same time, also found that the enterprise without permission during the inspection address within the store has a lot of good packaging contact lenses, and dismantling of glass bottles, aluminum foil cover, and the rotary evaporation apparatus, such as mixing apparatus, alleged in the address of the production behavior without permission.
The state administration of drug supervision, the state administration of drug administration, ordered the company to immediately suspend production and rectification, and to investigate the alleged violations of laws and regulations of enterprises in accordance with the law.
Jiangsu Helen contact lens co., LTD. : stop production
Product name: soft water contact lens, contact lens lubricant
There are two serious defects, including the inability to trace the use of packaging materials;The injection process cannot be traced back.
The state administration of drug supervision, jiangsu province, ordered companies to immediately suspend production and rectification.
Guangzhou kefu eyewear co., LTD. : stop production
Product name: soft wet contact lens
There are eight serious defects, including the specific production date of the product;The production batch number is inconsistent;The production record is not verifiable.
Guangdong's drug watchdog ordered companies to immediately suspend production and rectification, the regulator said.
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