Radiation-Emitting Products

Advice to a Facility Following a Serious Citation 

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Background:

During the Course III training and at other times, DMQS staff have received questions from inspectors about what to tell a facility with serious findings and whether or not the inspector should tell the facility to stop using certain personnel or certain equipment. When these questions arose, the standard response had been that inspectors cannot, using their authority under MQSA, order a facility to stop any practice that is or appears to be in violation of MQSA. Examples of these practices include (but are not limited to) using the services of unqualified personnel, using equipment which produces sub-standard phantom images, or using film processors which are developing out-of-limits.

During routine inspections, FDA does not delegate to inspectors or investigators the authority to make specific directives to a facility about what they must do concerning a noncompliance(s). While some inspectors believe they have the responsibility to make sure that a facility has stopped a practice that is in violation of MQSA, it is in fact, the facility's responsibility to comply with MQSA, and it is the inspector's responsibility to document these noncompliant items during the inspection process.

Supplemental Information Regarding State Authority:

Some States delegate authority to their inspectors to order a facility to stop a volatile practice or to stop performing mammography. The guidance described above is not designed to limit a State from exercising its authority with a facility that has been found to be in violation of State law or to prohibit State inspectors from exercising any authority delegated to them by State laws, regulations, or policies. However, when a State inspector takes such action at a mammography facility during an inspection, the inspector must make it clear to facility personnel that he/she is acting under and enforcing State law and not representing MQSA.

Questions:

 

Page Last Updated: 06/16/2014
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