FDA RESUME - Unknown Company

**FDA Document Summary: Lori B. Bury**

**Company Name:** U.S. Navy Civilian - Naval Hospital Camp Pendleton, CA

**Inspection Dates:** Not specified

**Main Violations/Issues:** - The document does not specify particular violations or issues. Instead, it highlights Lori B. Bury's role in overseeing quality assurance and compliance within the laboratory setting. Her responsibilities included identifying quality issues through root cause analysis and implementing corrective actions to align laboratory processes with best practices and regulatory requirements.

**Regulatory Framework:** - Compliance with federal regulations, state regulations, and accreditation standards from agencies such as AABB, College of American Pathology (CAP), Joint Commission (JC), and the Food and Drug Administration (FDA). - Ensured laboratory operations adhered to these regulatory frameworks, performing audits and providing recommendations for compliance.

**Required Actions:** - Develop and monitor quality assurance programs and process indicators across various laboratory services. - Conduct investigations and evaluations to identify adverse conditions and initiate corrective actions in blood and blood component manufacturing. - Track and trend corrective actions to assess their effectiveness. - Perform audits to verify compliance with accreditation agencies and regulatory bodies. - Provide advisory services regarding accreditation and regulatory compliance to laboratory supervisors and technicians. - Maintain and validate laboratory information systems and interfaces. - Mentor and provide guidance to laboratory staff and leadership on operations, compliance, and accreditation.

Lori B. Bury's extensive experience in quality assurance and compliance has been instrumental in maintaining high standards and regulatory adherence within the Naval Hospital's laboratory operations. Her leadership and problem-solving skills have contributed significantly to the facility's success in meeting regulatory requirements and ensuring quality patient services.