Medical network May 17 - May 16, the CFDA website for milli state giants Chinese medicine yinpian co., LTD and Chinese medicine yinpian WuShan County pharmaceutical company factory flight check. The report showed that the two companies had been notified of the flight inspections. 

 

Inspection found that nano state giants Chinese medicine yinpian co., LTD., there are a variety of violation of the "drugadministration law of the People's Republic of China" and drug GMP rules of behavior, the CFDA requirements in anhui province food and drug regulatory authority to recover the business related "medicine GMP certificate", supervision enterprise recall related products, to the enterprise behavior suspected of illegal production to initiate an investigation. 

 

And Chinese medicine yinpian WuShan County pharmaceutical company factory confirmed by the inspection and investigation, the enterprises in the pharmaceutical production license expires, according to the requirement of sales continue to WuShan County pharmaceutical companies in the name of the factory of Chinese medicine yinpian, many times from anhui, gansu west gansu medicine market purchasing Chinese medicine yinpian, before pharmaceutical companies of Chinese medicine yinpian warehouses set production points the batch number of the product, packaging and sales, no corresponding packing record, and sales of Chinese medicine yinpian quality inspection. In view of the pharmaceutical production license has expired and the pharmaceutical GMP certificate has been cancelled, the CFDA require the food and drug supervision bureau, gansu province to the enterprise behavior to initiate an investigation of alleged illegal production supervision enterprise recall related products. 

 

The company examined and discovered the problem 

 

The inspection report is not true. 

 

1. The frankincense (raw material batch number: 1183-161101) the original medicinal herbs in the inspection report, inspection items have a character, identification of 1, 2, identify check (magazine, sulfur dioxide residue), content determination. On-site inspection confirmed that the company did not do the products is required to identify 2 alpha pinene, not equipped with gas chromatograph polyethylene glycol (PEG - 20 m) capillary column, not the project detection ability, but the full inspection report issued by. The batch of 500 kg of raw materials has been made into vinegar frankincense and sold out. 

 

On the morning of March 10, 2017, the computer system of the high performance liquid phase chromatograph of the laboratory of the laboratory of the chemical laboratory was checked for April 10, 2017. Computer systems use log date/time have change, laboratory director lost interpreted as due to the part of the map, in order to keep the print to print the map with the monitoring report at the same time, computer time for the modification. 

 

3. Check the liquorice (raw material batch number: 1107-161101, 1107-161201, 161201-1107) the original medicinal materials inspection records is not standard behavior exist inspection report, the release of the reference substance, makes up records, licorice, inspection records and content determination of no on the spectrum of reference substance of liquorice glycosides, ammonium glycyrrhetate batch number, map without inspection and check the signature of the person to confirm. 

 

The sample records are not perfect, the raw materials sample records are not registered until January 21, 2017. The final sample of the finished product is not registered as of February 23, 2017. 

 

Second, there is suspicion of fabricating the production record. 

 

Site inspection found that the company 3, and 4 people gathered at the scene of the third floor of the quality department to write batch production records, after seeing the inspector all scattered, batch production records scattered been written on the desktop, after inspection group shows that attitude, businesses are starting to provide a lot of not binding of batch production records, such as: licorice: batch number 161201, platycladi seed: purslane, batch number, batch number is 161201, 161201, fleece-flower root: batch number: 161201, salt alisma: batch number: 161201, fructus rosae laevigatae meat: batch number: 161201, bone, skin, batch number: 161201. Have no batch production order, but the batch records "product releasing audit form" and "product releasing certificate" quality license per capita no sign, but the above products have clearance sales. 

 

The saff-proof product records show that since October 2016, the company has produced 3 sets of safflower (161101, 161201, 170201), but the enterprise cannot provide the batch record of 3 batches of products. 

 

3, material management chaos. 

 

The raw materials of the original medicinal materials, such as poria cocos (batch no. 1113-170301) 13580kg, were not seen in the original medicinal materials. 

 

All the drinks in the Chinese medicine are not set up in the warehouse, and the custodian only sells the products and sets up the inventory of finished products. 

 

The original medicinal materials are not registered as the origin of the classified accounts and the original medicinal materials, leading to the origin of Chinese medicinal materials and the origin of the source. For example, the "safflower" (batch number: 161101, 161201) shows the origin as "shandong", while the label of the finished packaging label is "Tibet". Mountain red paeonia (no. 161201) the inspection report is labeled as "Inner Mongolia", but the production record of the net optional post is "shanxi". There are no signs on the packaging of mother-grass, blue root and cocos, and workers simply write the origin on the material card with experience. 

 

Fourth, production site management is not standardized. 

 

1. Salvia miltiorrhiza in batch production records (170201), the production order is issued on February 17, 2017, the batch is 1000 kg, and the requisition according to this batch production actual receive salvia miltiorrhiza 200 kg, net choose post production records show that dosage of medicine led to a total of 180, before and after production. 

 

2. Wine fructus ligustri lucidi (20161001) batch production records excipients dosage is inconsistent, yellow rice wine production order 200 kilograms, dosage of cooking post 150 kilograms, the lack of yellow rice wine material requisition, the actual process parameters did not fill in. 

 

The company can not provide the use of the main production equipment such as rotary disc cutting machine, calcining machine, and stir-frying machine. 

 

The medical company of wushan county medical co., LTD. Has examined and discovered the problem 

 

WuShan County pharmaceutical companies for WuShan County pharmaceutical company subordinate enterprises, Chinese medicine yinpian factory is located in WuShan County los door town prosperity road no. 97, the pharmaceutical production license in 12 years. 31, 2015, due to the corresponding "medicine GMP certificate" (GS20140105) is valid until September 29, 2019. According to ShengJu "about < > pharmaceutical production license issued by the gansu province replacement and < > preparations of medical institutions permit work plan notice requirements, the enterprise the pharmaceutical production license is valid until March 31, 2016, expires this enterprise to stop production, production after the plant has been leased. The inspection team traveled to the area to confirm that there were no other personnel outside the janitor and no production facilities in the factory. In August 2016, the food and drug administration of gansu province announced the cancellation of its pharmaceutical GMP certificate. On February 13, 2017, its business license is cancelled. 

 

WuShan County pharmaceutical company is a state-owned enterprise, founded in 2015 in WuShan County town industrial park built a factory of Chinese medicine yinpian, new factory main architecture completed in September 2016, and on January 26, 2016 in the industrial and commercial administrative departments to obtain a business license, enterprise registration name for "fu xi in gansu province pharmaceutical co., LTD.", but the company has yet to achieve the pharmaceutical production license. 

 

Because Chinese medicine yinpian WuShan County pharmaceutical company factory affiliated to the state-owned enterprise WuShan County pharmaceutical companies, so the inspection group of WuShan County pharmaceutical companies to check. Examination found that WuShan County pharmaceutical company warehouse still have a lot of the original factory production slices of traditional Chinese medicine yinpian, according to the original enterprise scale, production time span and the sales of Chinese medicine yinpian, team to judge the unreasonable situation existed, then with the enterprise legal representative, general manager xu, xu in the process of YingJian gradually realized the serious problem of the enterprise, that night to the inspection group active admitted violation behavior, and to ensure that the next day for business related personnel inspection group investigation. 

 

Then, the inspection team, with the coordination of the bureau of the gansu bureau and the inspection bureau of the tianshui municipal bureau, asked nine relevant personnel to investigate and investigate the written records. 

 

Confirmed by the survey, the enterprises in the pharmaceutical production license expires, according to the requirement of sales to continue in the name of Chinese medicine yinpian WuShan County pharmaceutical company factory, many times from anhui, gansu west gansu medicine market purchasing Chinese medicine yinpian, before pharmaceutical companies of Chinese medicine yinpian warehouses set production points the batch number of the product, packaging and sales, no corresponding packing record, and sales of Chinese medicine yinpian quality inspection.