BTS Research Addresses FDA Warning Letter Satisfactorily

btsresearchLogo

BTS Research Addresses FDA Warning Letter Satisfactorily

From the desk of the President & CEO, April 1st, 2024

BTS is very pleased to have received a satisfactory completion of the findings the FDA had issued a warning letter on October 20th 2023. The findings were originally noted during their June 27th 2022 audit, which centered around tighter Study Director’s reviews and communications, more detailed inspection of records by the QAU and updating some equipment. This was in response to the FDA drug submission in Phase I.

We are very pleased that we were able to address and close the warning letter items in two work weeks, between Oct 20th and Nov 8th 2023, Said Sam Abunadi, President & CEO. Sam also added that “we are also very pleased that these GLP studies facilitated the approval for our client without delay.”