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Party: Guangxi Huatianbao Pharmaceutical Co., Ltd. Illegal Facts: Law enforcement officials of our Bureau from October 27, 2020 to October 28, 2020, in accordance with the law to carry out daily supervision and inspection of the production of drugs.
inspection found that the parties suspected of not handling batch numbers 171101 and 171102 in accordance with the quality management norms of drug production, respectively, over the validity of the Guilong drug and wine behavior, to be investigated.
Upon investigation, on 27 October 2020, the parties arranged for two female staff members to change the batch number 171101 and 171102 guilong medicine wine in a one-story warehouse between the dormitory building and the office building in the production plant, and the original packaging cartons and the newly replaced packaging cartons were placed in the u-labeled guilong medicine liquor.
Upon investigation, the parties have registered the above two batches of guilong medicine wine over the validity period for destruction on September 28, 2019, the destruction record of non-conforming products registered batch number 171101 guilong medicine wine destroyed 364 38 bottles (total 14598 bottles) and batch number 171102 guilong medicine wine destroyed 658 (total 26320 bottles).
The parties in the destruction of 14080 bottles of cinnamon wine, because two batches of cinnamon wine related to the purchase and sale of agents, is fighting a lawsuit with agents, so at the behest of the legal representative Chen Dingxian, asked not to deal with the above-mentioned more than the validity period of cinnamon wine for the time being.
By the material department head Long Wei will be the remaining undressed batch number 171101 and batch number 171102 Guilong medicine wine pulled to the dormitory building and office building between a first-floor warehouse storage, the storage warehouse has no specific labeling purpose, number, no temperature and humidity control facilities equipment, no establishment of a location card, no red non-conforming status identification.
because the above-mentioned more than the validity of the number of guilong medicine wine, the original enterprise set up a non-conforming goods warehouse can not be stored, so there is no storage in the non-conforming goods warehouse.
the parties to replace the carton, ready to be taken by the boss or sales department to send people.
The nature of the case, discretionary facts and reasons The parties did not store more than the validity period of guilong medicine wine in the enterprise set up a warehouse of non-conforming goods but placed in the undated use, number, also no temperature and humidity control facilities between the building and office building between a one-story warehouse storage, not in accordance with the established operating procedures to deal with non-conformity Guilong medicine and alcohol and other acts, do not comply with the relevant provisions of the drug production quality management norms, in violation of the People's Republic of China Drug Administration Law, Article 43, paragraph 1, "to engage in drug production activities, should abide by the drug production quality management norms, establish and improve the quality management system of drug production, to ensure that the whole process of drug production in accordance with the statutory requirements."
the investigation of the case, the parties can take the initiative to admit the facts, actively cooperate with law enforcement officials to investigate and collect evidence, resulting in minor harmful consequences.
In accordance with the provisions of Article 27 (1) (4) of the Administrative Punishment Law of the People's Republic of China and the Regulations on the Application of Administrative Penalties for Drugs and Medical Devices (No. 306 of the State Food and Drug Administration Law (2012) No. 306), the circumstances of the light punishment are met.
the contents and basis of the administrative penalties, in accordance with the provisions of Article 126 of the Drug Administration Law of the People's Republic of China, this Council has decided to make the following administrative penalties to the parties concerned: Warning.