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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Levels of Non-Compliance [Observations] (Definition)

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Discussion:

FDA has classified each adverse inspection observation into one of three 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. A Level 3 observation indicates that the facility meets all major MQSA requirements with only minor problems. Adverse inspection observations are placed into a category level based on 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.