Quality System Audits

Once a quality system is in place, manufacturers must conduct routine audits to ensure their system is compliant and effective. Without regular monitoring, there may be a reduction in product quality or a lack of process improvement, resulting in either a possible loss of third-party certification or FDA enforcement actions. MCRA’s experts can assess your compliance and prepare you for FDA inspections and notified body audits to keep you in compliance.


  • Perform mock FDA inspections to assess QSR compliance
  • Perform supplier audits; reducing your internal cost by outsourcing this requirement
  • Perform internal audits; reducing your internal cost byoutsourcing this requirement

To contact a quality assurance expert at MCRA, call 202.552.5800 or email

MCRA is not a law firm and neither provides legal advice to its clients nor can affirm the legal or regulatory validity of the materials of which it provides. MCRA recommends that its clients consult an attorney to discuss any legal issues that relate to its business and/or MCRA services

People & Expertise



Quality Assurance

Mr. Biggins has over twenty years of experience in the area of Quality Systems and Manufacturing beginning as a Quality Engineering Manager. Mr. Biggins is an expert at Quality Management Systems, specifically in the areas of Corrective and Preventive Action (CAPA), Customer Complaints, Design Control Read More