Responding to FDA after Inspections with Adverse Observations
Facilities need to understand how to respond if they have received an adverse observation(s) during their inspection. Facilities need to respond in writing to any inspections with higher than a Level 3 observation. For repeated Level 1, Level 1 and repeated Level 2 observations, the facility should respond within 15 working days after it receives its inspection results. For Level 2 and repeated Level 3 observations, the facility should respond within 30 working days after it receives its inspection results. Non-repeated Level 3 observations do not need to be addressed in writing. However, these observations must be corrected and these corrections would normally be checked during the next annual inspection. Inspectors and facilities in Certifying States should contact their State Certifying Agency to determine the policies that apply to them. The inspector should make sure that facility personnel understand what they should do and/or what will happen after the inspection is over.
Corrective Action Communication:
For any facility inspection, the inspector should give facility personnel two separate documents:
A cover letter entitled “Important Information about Your MQSA Inspection” (with the appropriate section checked off by the inspector);
The post-inspection report (MQSA Facility Inspection Report).
These documents, along with verbal instructions, should be issued to the appropriate personnel at the facility. Inspectors are strongly encouraged to attempt to discuss the observations with the most responsible official available at the time of the inspection. The inspector should also explain how to submit the facility response to the appropriate FDA district (or regional) office (or State Certifying Agency where applicable), with the State radiation control office receiving a copy. The inspector might also mention that the facility response to the inspection observations should not be sent to the Division of Mammography Quality Standards (DMQS) address in Silver Spring, Maryland or the FDA address in Columbia. These addresses should only be used if the facility intends to comment on the inspection process in general. Inspectors and facilities in Certifying States should contact their State Certifying Agency to determine the policies that apply to them.
Facility Comments/Questions about Inspections
Facilities should only use the Facility Hotline number (1-800-838-7715) for general comments about the inspection process and general MQSA questions, not to ask inspection-specific questions. If personnel at a facility have inspection-specific questions relevant to an upcoming or recent inspection, they should contact the MQSA Inspector who conducted the inspection, or the State radiation control office. If the inspector cannot answer the questions, the FDA district office or DMQS should be contacted.