YBS Biographer Newsletter
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Successful FDA Inspection
Date Posted:  11 April 2018
Summary:  We are pleased to announce the successful completion of a three-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 three-day inspection by the United States Food and Drug Administration (FDA) of our bioanalytical facility in York.

On March 19, 2018, two investigators from the FDA Office of Study Integrity and Surveillance visited YBS’s facility in York for a routine inspection to assess our overall compliance with current regulations. During the unannounced visit, the investigators toured the facility and laboratory areas, performed in-depth reviews of several method validations and four sample analysis 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 GLP and GCP inspections by the UK regulatory authority the Medicines and Healthcare Products Regulatory Authority (MHRA), during which we have never received a major or critical finding.

“The success of this FDA inspection reflects our excellent quality standards delivered by our highly skilled and experienced scientific and quality assurance teams at YBS”, stated Ian Smith, Managing Director Operations at York Bioanalytical Solutions.




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