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Borui Medicine passed the FDA inspection

  • Categories:NEW
  • Author:
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  • Time of issue:2017-12-08 14:43
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Borui Medicine passed the FDA inspection

(Summary description)On December 8, 2017, Borui Biomedical (Suzhou) Co., Ltd. passed the US Food and Drug Administration (USFDA) on-site inspection with "zero defects".

  • Categories:NEW
  • Author:
  • Origin:
  • Time of issue:2017-12-08 14:43
  • Views:0
Information
1

On December 8, 2017, Borui Biomedical (Suzhou) Co., Ltd. passed the US Food and Drug Administration (USFDA) on-site inspection with "zero defects".

The inspector carried out a five-day comprehensive and systematic inspection of Borui Pharmaceutical's entire production quality system. The on-site inspection did not follow a fixed process, but interspersed the document review and various on-site inspections. The inspection content covered all six major systems of QA, QC, production, materials, equipment and facilities, and packaging and labeling.

The inspector is experienced, and the inspection process is meticulous and does not miss any details. Finally, the prosecutor determined that Borui Pharmaceutical has established a complete cGMP management system, equipped with corresponding technical management personnel, complete production and inspection facilities and equipment, comprehensive documentation system, sound production and quality management system, and a good production quality management system for Borui Pharmaceutical . Give full affirmation. In the end, Borui Pharmaceutical passed the USFDA inspection with "zero defects". This laid a solid foundation for Borui Pharmaceuticals to expand into the US market, and is another important milestone for the company's development.

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Borui Medicine

address:

Building C25-28, 218 Xinghu Road, Suzhou Industrial Park, Jiangsu Province, China

Borui Medicine

phone:

0512-62620988

 

Borui Medicine

Fax:
0512-62551799

Copyright: Brilliant Biomedical (Suzhou) Co., Ltd. Website: CE Dongli · Suzhou Su ICP No. 18,000,014           

Copyright: Borui Biomedical (Suzhou) Co., Ltd. 

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