FDA EIR - Bioreliance Corporation - August 08, 2019

BioReliance Corporation in Rockville, MD, was the subject of an FDA inspection conducted from August 6 to August 8, 2019. This comprehensive review assessed the company's adherence to Good Laboratory Practice (GLP) regulations, specifically CP 7348.808, and overall compliance with the FD&C Act concerning nonclinical laboratory studies. Upon conclusion, the FDA issued a five-item Form FDA 483, highlighting several significant observations. Primary issues included a failure to ensure that personnel, particularly archivists, fully understood their roles and could independently access necessary Standard Operating Procedures. The facility's archives also presented multiple security and operational deficiencies: the archive was not consistently locked, documents were found unsecured outside the designated area for extended periods, and unauthorized individuals accessed the archive without proper logging. Furthermore, the company failed to maintain an accurate and current inventory of archived study documents, impacting traceability. Another observation noted the designation of multiple 'archivists,' which deviates from GLP requirements for a single responsible individual. Additional findings cited an outdated electronic inventory for test articles and unaddressed deficiencies in vivarium equipment maintenance due to unclear staff responsibilities. These observations underscore the need for BioReliance to implement prompt and comprehensive corrective actions to align with regulatory standards and safeguard the integrity of their GLP study data.