It turns out that Binex and Non-Preservation Pharmaceuticals have arbitrarily added additives or changed the amount of raw materials used without a separate approval procedure, and their manufacturing records were falsely duplicated.
The Ministry of Food and Drug Safety announced the results of an administrative investigation conducted on Binex and non-preservative pharmaceuticals on the 25th.
As a result of conducting an administrative investigation on Binex and non-preservative pharmaceuticals, the Ministry of Food and Drug Safety confirmed that they used additives arbitrarily without permission for change. Also, in preparation for inspection by the Ministry of Food and Drug Safety, a false manufacturing record was written in the same format as the matters for which all processes were approved, and then the records used for actual manufacturing were duplicated by discarding after manufacture.
In addition, violations of the Pharmaceutical Affairs Law were confirmed for Binex and non-preservative pharmaceuticals, such as unchanged manufacturing method and arbitrary increase or decrease in the use of raw materials.
The Ministry of Food and Drug Safety was concerned about the concealment and disposal of documents related to Binex and non-preservation pharmaceuticals during the administrative investigation, so it quickly switched to investigation to confirm additional violations, and is planning to take serious administrative measures.
The Ministry of Food and Drug Safety said, “We will thoroughly and promptly conduct investigations on Binex and non-conservative pharmaceuticals currently underway, disclose the results transparently, and take necessary measures.” “We will actively promote effective system improvement measures such as strengthening the level of drug safety management.”
In addition, the Ministry of Food and Drug Safety inspected 29 consignment companies that manufacture and consign drugs with the same ingredients and formulations as the products with which the violation was confirmed to Binex and non-preservative pharmaceuticals, and as a result, it confirmed violations of negligence in management and supervision of the consignee. Accordingly, the Ministry of Food and Drug Safety is planning to take administrative measures and other measures.
The Ministry of Food and Drug Safety said, “29 consignment companies are 24 companies (32 items) related to Binex and 5 companies (5 items) related to non-preservative pharmaceuticals. As a result of direct inspection of products that have been found to be violating, the content etc. are within the test criteria. Therefore, it is judged that there will be little harm to the human body.”
In addition, the Ministry of Food and Drug Safety conducted an emergency special inspection at 30 consignment and consignment factories nationwide to check cases similar to Binex and Non-Preservation.
As a result of the special inspection, no cases of violations identical to those of Binex and non-preservative pharmaceuticals were confirmed, but one site is expected to confirm the violation of drug manufacturing and quality control standards and take administrative measures.
The company manufactured it in accordance with the license requirements, and there were no intentional misconduct such as concealing or disposing of related documents, but violations such as failure to test finished products and raw materials, and not preparing part of the product standard were confirmed.
The Ministry of Food and Drug Safety said, “To prevent the recurrence of intentional violations of manufacturing and quality control standards, ▲ a special drug GMP special planning and inspection team was established to conduct irregular inspections on a regular basis, and ▲ set up and operate a’report center’ for violations, etc. He said, “We will strengthen the inspection system for drug manufacturing and quality control, such as improving the structure of the related permit system and enhancing the effectiveness of penalties.”
The drug GMP special planning and inspection team plans to establish an unannounced inspection system throughout the year, in addition to regular monitoring of the current three-year manufacturing plant, and conduct detailed inspections on whether manufacturers comply with manufacturing and quality control standards.
The’Clean Report Center for Drug Manufacturing and Quality Illegal Activities’ was established to operate an efficient year-round unannounced inspection system, and a hotline that allows all citizens to easily report intentional and illegal activities anonymously (the KFDA website, phone 043-719- 2699, e-mail [email protected]) is planned to be operated from April.
The Ministry of Food and Drug Safety said, “We will cancel the GMP conformity determination for illegal acts such as intentionally changing manufacturing methods and creating false or double records, and will pursue measures to impose punitive penalties for unfair profits obtained through the violation.” · In order to reinforce the quality responsibility of the consignees, the administrative disposition for non-compliance with the consignees and consignees will be raised,” he emphasized.