Follow Up for MQSA Inspection Violations

The FDA classifies each adverse inspection observation into one of two category levels.  A Level 1 observation indicates a failure to meet a key MQSA requirement that may compromise the quality of mammography performed at the facility. A Level 2 observation indicates that the facility meets all key MQSA requirements but fails to meet a significant mammography quality item. Adverse inspection observations are placed into a category level based on the FDA’s assessment of how the observation may affect the quality of mammography. The category level is also used to determine how the facility should respond to the observation. Identical observations found during two consecutive inspections are identified as repeats.

• For a Level 1, repeat Level 1, or repeat Level 2 observation, the facility must correct the problem(s) as soon as possible and submit written correspondence identifying all corrective action(s) that have been taken to the FDA compliance officer identified in the “Important Information about Your Mammography Quality Standards Act (MQSA) Inspection” document, within 15 working days of receiving the inspection report. 
• For a Level 2 observation, the facility must correct the problem(s) as soon as possible and submit written correspondence identifying all corrective action(s) that have been taken to the FDA compliance officer identified in the “Important Information about Your Mammography Quality Standards Act (MQSA) Inspection” document within 30 working days of receiving the inspection report.

Facilities should also address any inspectional observations noted in the printable remarks in its response to the FDA compliance officer.  If the facility’s response to the inspection’s observations appears adequate, the FDA may decide that no further action is needed and will notify the facility that the matter is closed. 

If the facility’s written response to the inspection observations is not sufficient or the facility fails to respond, the FDA may need to re-inspect the facility to verify that it has corrected all of the problems. The cost of this inspection is $1144. The FDA may also decide to issue a Warning Letter, and/or other regulatory action, such as an Additional Mammography Review (AMR), Directed Plans of Correction, Civil Money Penalties, Suspension or Revocation of an MQSA certificate.

Note: Repeat Level 2 observations associated with the Enhancing Quality Using the Inspection Program (EQUIP) initiative require the facility to undergo an AMR performed by the facility’s accreditation body. Additionally, based on observations identified during an inspection, a facility may be required to undergo AMR when the FDA or Certifying State has reason to believe that mammography quality has been compromised and may present a serious risk to human health, regardless of whether a facility has taken corrective action(s) and submitted its response to the FDA or not.