Shaanxi Provincial Health Products Supervision Office
From March 8th to 15th, the Provincial Health Products Supervision Office organized the Provincial Food Safety Supervision Center and the Provincial Food and Drug Inspection and Research Institute professional and technical personnel to carry out a joint stock company of Xi'an Sanjiang Biotechnology Co., Ltd., Shaanxi Tianxingjian Biotechnology Co., Ltd., Shaanxi Natural Valley Biotechnology Co., Ltd., Yangling Cuijian Bioengineering Technology Co., Ltd., Xi'an Tianyi Biotechnology joint stock company, Shaanxi Jiahe Biotechnology joint stock companyPlant extractsQuality management status special project inspection.
The key inspection of the enterprise's product inspection and stability inspection implementation, the inspection team conducted a key inspection of the enterprise laboratory and sample room. Through inspection, it was found that the product inspection system and inspection equipment of Shaanxi Tianxingjian Biotechnology Co., Ltd. were relatively sound, and the stability inspection system was implemented, but there were still problems such as unreasonable laboratory layout, mixing of heat test equipment with other equipment, and insufficient number of samples retained; Xi'an Sanjiang Biotechnology Co., Ltd. had insufficient quality inspection equipment, unable to provide full inspection of ex-factory products, no stability inspection system to carry out stability inspection, no stability accelerated test equipment, and the retention sample could not guarantee the stability inspection test. The retention sample was not stored in the sample room and other problems; Hanzhong Natural Valley Biotechnology joint stock company 101 electric blast drying oven and vertical pressure steam sterilizer had no verification and calibration certificate, and the sample room had no temperature and humidity meter and record for environmental testing, and the humidity did not meet the requirements of the retention sample No heavy metal detection equipment, no pathogenic bacteria laboratory, no stability test equipment and conditions, pesticide residue testing has not been carried out; Xi'an Tianyi biotechnology joint stock company inspection site did not see Escherichia coli incubator, product "stability inspection management regulations", "product retention management regulations" need to be revised in accordance with the national standard; Yangling Cuijian Bioengineering Technology Co., Ltd. retained sample room temperature and humidity meter verification valid period expired, arsenic, mercury can not be self-test; Shaanxi Jiahe biotechnology joint stock company meets the requirements of product quality inspection.
According to the inspection results, the inspection team of Xi'an Sanjiang Biotechnology Co., Ltd., and Shaanxi natural valley biotechnology joint stock company issued an immediate suspension of rectification opinions, and handed over to the local food and drug regulatory authorities to supervise the implementation of enterprise rectification; Shaanxi Tianxingjian Biotechnology Co., Ltd., Yangling Cuijian Bioengineering Technology Co., Ltd., Xi'an Tianyi Biotechnology joint stock company issued rectification opinions, requiring enterprises to immediately take effective measures to correct the problems detected.
