FDA EIR - Bioreliance Corporation - September 29, 2008

An FDA directed-routine inspection of BioReliance Corporation in Rockville, MD, was conducted from September 8 to September 29, 2008, under Good Laboratory Practice (GLP) regulations (CPGM 7348.808). The inspection identified several critical deficiencies, resulting in the issuance of an FDA Form 483. Main violations included significant lapses in animal husbandry, such as animals found dead or hunched, potentially due to lack of food, and extended periods where mouse cages were not sanitized, introducing uncontrolled variables into studies. The Quality Assurance Unit was found to have failed in detecting these deviations and also exhibited deficiencies in ensuring the Study Director's GLP training was current. Furthermore, the Study Director did not ensure adherence to protocols regarding animal feeding and cage sanitation. The inspection also revealed a lack of stability determination for test article cells in injection vehicles and insufficient testing to assure uniformity and concentration of test articles. Other observations included the omission of clinical observations in final pathology reports and the need for improved tracking of animal locations, detection of adventitious agents, and verification of inoculation procedures. BioReliance management acknowledged the findings and committed to providing a written response to the FDA Form 483 within 30 days, outlining corrective actions. Some voluntary corrections were also initiated during the inspection.