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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Inspection Findings Disputed By Facilities

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In some cases, the facility may disagree with the inspector's findings. The following guidance pertains to these situations.

Note that when a facility has been cited as the result of an MQSA inspection, regardless of whether it is a Level 1, 2 or 3 finding, the facility has the right to disagree with the inspection findings.

Level 1 and Level 2 Findings

For Level 1 (Warning Letter) and Level 2 findings, the facility is required to submit a written response to the finding(s). Please follow the following steps for these situations.

1. When a facility notifies the FDA district office in writing of a disagreement with the findings from an inspection, the district should obtain facility information about the disagreement and contact the State and/or inspector to assess what the inspector found.

2. If it is determined that the inspector was incorrect:

a) The inspector should download the inspection record, correct the inspection data, and upload the corrected inspection record within 10 days after being informed of the need for correction. A new MQSA Facility Inspection Report should be printed and submitted by FAX or mail to the FDA district office.

b) The FDA district office should respond to the facility by letter (a phone call is optional) with regard to the disputed finding(s), indicating that FDA agrees with the facility, and that the inspection data for this area has been modified to reflect the correction(s). The revised MQSA Facility Inspection Report should be included with the letter to the facility. FDA should contact the facility by letter within 30 days after notification by the facility of the disagreement with the inspection findings.

Note: The facility should not be informed of any changes before the revised inspection data has been uploaded to MPRIS.

3. The inspector is believed to be correct:

a) If the matter pertains to a disagreement regarding policy, the FDA district office should contact DMQRP, via e-mail, regarding the dispute. Facts concerning the disputed findings should be included with this E-mail.

b) If the matter pertains to a disagreement regarding facts or data for the inspection, the FDA district office should resolve the disagreement by contacting the facility and the State. The district office may contact DMQRP for additional guidance, when needed.

c) If the inspector is found to be in error, then follow 2a and 2b above.

d) If the inspector is correct, the district office should send a letter to the facility indicating that FDA supports the findings of the inspection and that the facility has a responsibility to correct the problems found. In those cases where contact has been made with DMQRP regarding the inspection, this should be stated in the letter to the facility. If a Warning Letter was sent and the disagreement arose from the letter, the response back to the facility should reiterate the intent of the FDA to take action should the facility fail to comply with MQSA.

Level 3 Findings

Level 3 findings are the least severe and do not require a response by the facility. However, many facilities will respond to these findings by letter to either the State or FDA. If the facility disputes a Level 3 finding, then the steps listed above should be followed.

Inspection Errors Discovered by FDA or the State

Inspection records containing errors need to be corrected, regardless of whether the finding(s) was disputed by the facility. In cases where errors are found by the FDA or the State, rather than the facility, the inspector should 1) correct the inspection record, 2) print the report, 3) upload the revised record to MPRIS, and 4) mail or FAX the report to the facility along with either a note or letter from the State explaining that a correction of the report was necessary. The State or the inspector may also call the facility about the correction, as long as the revised report is mailed before or after the call.