Latest News from York Bio
Successful FDA Inspection
18 October 2021
We are pleased to announce the successful completion of a four-day inspection by the United States Food and Drug Administration (FDA) of our bioanalytical facility in York.
We are pleased to announce the successful completion of a four-day inspection by the United States Food and Drug Administration (FDA) of our bioanalytical facility in York.
On September 13, 2021, the FDA Office of Study Integrity and Surveillance Center for Drug Evaluation and Research performed a remote audit of YBS’s facility in York for a program of bioequivalence studies. During the remote audit, investigators performed in-depth data reviews of ten bioequivalence studies. Upon completion of the inspection, the investigators reported zero observations, with only a few minor discussion points raised.
This inspection follows a long history of successful inspections by the UK regulatory authority the Medicines and Healthcare Products Regulatory Authority (MHRA) and the FDA.