From 27th to 30th June 2016, the inspector of U.S. FDA (Food and Drug Administration) carried out on-site inspection to Shijiazhuang Rainbowlabs Pharmaceutical Technology Co., Ltd (hereinafter referred to as Rainbowlabs) and made Zero 483 conclusion on the date of 30th June. It signifies the Rainbowlabs has passed the U.S. FDA audit again with full marks.
In present times, FDA carries out increasingly strict inspections to Chinese pharmaceutical industry and data integrity problems frequently emerge, it is really difficult to reach the ‘zero 483’ conclusion.
The U.S. FDA is recognized as the most authoritative and strictest global pharmaceutical quality control organization. In July 2013, Rainbowlabs firstly passed the FDA on-site inspection with Zero 483 and became the first high tech company who passed FDA inspection as a third party testing laboratory. Today, Rainbowlabs’ outstanding performance with Zero 483 proved the professionalism of our quality system and detection system. It marks Rainbowlabs has reached the highest international standards of GMP benchmarking Enterprise.
Rainbowlabs passed the U.S. FDA inspection again, which will play a significant and promoting role to help domestic pharmaceutical companies to overcome technical & trade barriers and access to European and American high-end medical market. At the same time, we will set a new quality standard for Chinese bio-pharmaceutical industries in accordance with the highest international standards of quality to proceed new products development and new technology research.