CCTV News:Recently, the temperature has continued to fall, and the number of cold patients has increased significantly. Various cold medicines have become "standing medicines"! However, please note that the State Food and Drug Administration recently issued a notice saying that Shenyang Xindi Pharmaceutical Co., Ltd. was suspected of illegally producing chlorphenamine maleate, and requested to stop using it immediately!
Flight inspection by the General Administration, pharmaceutical companies seriously violated the law.
A few days ago, the State Food and Drug Administration issued a notice saying that according to reports from the masses, the General Administration organized a flight inspection of Shenyang Xindi Pharmaceutical Co., Ltd. and found that the company was suspected of serious violations of laws and regulations. Initially, it was found that the enterprise:
In violation of the approved production process, the raw material of chlorphenamine maleate was produced by purchasing the intermediate chlorphenamine maleate instead of the feed production of p-cyanobenzyl chloride.
Records and data such as material source, batch production records, batch inspection records, inspection reports, product review and release documents are not true, so it is impossible to trace the process of drug production and quality control.
Do not cooperate with the inspection team.
The country immediately stopped selling and recalled.
According to public information, chlorpheniramine maleate bulk drug preparations include tablets and injections, also known as chlorpheniramine. Mainly used for rhinitis, skin and mucous membrane allergy and relieving cold symptoms such as tears, sneezing and runny nose. This raw material medicine involves many kinds of preparations, such as pediatric paracetamol, chlorphenamine maleate, vitamin C Yinqiao tablets, Keteling capsules, Biyan tablets and so on.
The General Administration requires:
All operating and using units,Stop selling and using immediately.Marked as chlorphenamine maleate raw material medicine produced by Shenyang Xindi Pharmaceutical Co., Ltd. in 2017.
Liaoning Food and Drug Administration should supervise enterprises to recall all chlorphenamine maleate raw materials produced in 2017, and the food and drug supervision departments of relevant provinces (autonomous regions and municipalities) should actively cooperate.Do a good job of recall.
It is understood that the Liaoning Food and Drug Administration has recently filed an investigation on the enterprise.After testing the relevant API products involved in the case according to the Pharmacopoeia, no unqualified situation was found.The company was strictly investigated mainly for compliance issues.
Require all localities to intensify inspections.
China food and drug administration requires that all API manufacturers earnestly implement the main responsibility and strictly follow the approved process to ensure that the whole process records are true, complete and traceable.
The relevant person in charge of the Department of Pharmaceutical Supervision of the Food and Drug Administration said that the General Administration will urge enterprises to continue to comply with production through various forms of inspections in the future. The food and drug supervision and administration departments of all provinces (autonomous regions and municipalities) are required to perform their duties according to law, intensify the inspection of production enterprises, pay attention to all kinds of risk signals and clues, and find any illegal acts suspected of violating the approved process production, untrue or incomplete records, etc., and all of them will be investigated and punished according to law.