BTS Research Passes an FDA Bioresearch Monitoring Program Inspection for GLP Rat and Dog Toxicity Studies

By January 22, 2020 News No Comments

BTS Research is pleased to share with its clients the results of the FDA audit which was concluded on December 4th, 2019.

Following a 14-day onsite inspection, the FDA concluded their inspection of a 2-week GLP Rat Intravenous study and a 26-Week GLP Oral dog study for two of BTS’ clients. The FDA affirmed that the studies have been performed under the Good Laboratory Practice for Nonclinical Studies regulations [Title 21, Code of Federal Regulations, Part 58].

“We are very pleased with the inspection results especially that the inspection came at a time when BTS Research was in the middle of downsizing their facilities footprint, moving into their new lab and doing a financial restructure.” Mr. Sami Abunadi, President & CEO said.

“We couldn’t have done that without the dedication and the quality of work the BTS Team possess”.  Mr. Abunadi added.

BTS Research is a Discovery through IND preclinical CRO located in San Diego offering Inflammation, metabolic, Cancer and Device research in all regulated species (Rodents, Rabbits, Dogs, Pigs and NHP’s).

The downsizing came after major clients of BTS Research concluded their long-term programs in 2017 and their old facility went through a major obstructive construction.

San Diego, Ca.
January 21st, 2020

FDA Response Letter.