US FDA GMP Auditing Services

Health Policy Associates is the internationally recognized leader in assisting medical device manufacturers with FDA inspections, communications, and responses. For more than 20 years, HPA Inc. has been providing consulting expertise bringing innovative new medical devices to market.

Preventing and resolving compliance issues for new medical products requires specialized expertise in developing and implementing GMP (Good Manufacturing Practice) quality systems. Understanding FDA’s and international regulations compliance requirements, and managing interactions with regulatory agencies during audit and inspection processes are integral parts of the process.

Our services include:

FDA QSR (Quality System Regulation) mock audits to help prepare for an FDA inspection that mimic the FDA GMP inspection process and provide an unbiased assessment of readiness for an actual FDA inspection
FDA Pre-inspection Audits to evaluate the preparedness of manufacturing facilities for regulatory inspections and conducting gap analyses or internal GMP audits to identify problem areas in quality system complaint handling, design control, corrective action, and manufacturing processes
Gap analyses to determine current compliance with FDA regulations specific to 21 CRF Part 820 requirements, pinpointing any problem areas in current quality systems
Full or Partial Internal GMP Audits to provide an independent review of the full quality management system and to ensure compliance with the FDA requirement for regular GMP quality management systems and processes audits