Radiation-Emitting Products

Should inspectors tell facility personnel during the inspection that they must stop the specific practice(s) which resulted in a serious citation(s)?

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When a serious problem (such a Level 1 finding) is identified at a facility, the inspector should tell facility personnel that, in the interest of public health, he/she recommends they discontinue using the equipment, personnel, or practice that resulted in this serious noncompliant finding. The inspector should also mention that there are sanctions which the facility could be subject to should the noncompliant finding continue.

Examples of sanctions include the imposition of a Directed Plan of Correction (specific orders by FDA identifying how a facility must correct their noncompliant finding{s}), civil money penalties (up to $10,000 per day per noncompliance), suspension or revocation of their MQSA facility certificate, or an injunction. The inspector may also indicate that continuing to use or to perform the cited item while the violative condition exists adds to the violations already found and that it would be in the best interest of the facility to correct the problems immediately.

Back to Advice to a Facility Following a Serious Citation

Page Last Updated: 08/11/2014
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