Recording State vs. MQSA Requirements

FDA understands that it is both more efficient for inspectors and less disruptive for facilities when the State and MQSA inspections are performed together. However, it is important that inspectors take special care in communicating with facility personnel regarding which observations are State requirements versus MQSA requirements. This means that inspectors should clearly state when a citation is a State noncompliance and when a citation is an MQSA noncompliance.

Additionally, State noncompliances should not be listed on the MQSA Facility Inspection Report (including the printed Remarks sections), in the inspection cover letters, or any other documents created for the MQSA inspection program. All State noncompliances should be placed on the appropriate State forms, documents, or letters to the facility.