Discussion:
An inspector should not routinely cite a facility for Level 2 or 3 noncompliant finding(s) that occurred since the last inspection and were then corrected before the current inspection. These corrected problems could be in any part of the inspection. The most likely areas where this policy could be applied would be for quality control testing or personnel qualifications. Consideration needs to be given to those facilities that discover and correct their problem(s) before the problem(s) gets worse. Inspectors should use the printable Remarks Section to record the problematic finding(s) and verify that it had been CBI. During the exit interview at the end of the inspection, the inspector should remind facility personnel that the noncompliance should not be allowed to recur. The historical record entered into the Remarks Section(s) and the discussion during the exit interview is important, should the facility have serious problems later and FDA considers action against the facility in the future.
Since inspector observations and judgment are crucial in making a determination as to whether a facility has permanently corrected a problem, the following examples are provided as some guidance to help the inspector in making this determination.
When a noncompliance is found to have previously occurred, but is no longer present at the time of the inspection, the facility should be able to provide an explanation of what actions were taken to correct the problem. If facility personnel do not know why/how the problem was resolved or do not even know the problem existed, an inspector may assume that the noncompliance was not corrected by actions of the facility personnel. Furthermore, noncompliant item(s) that are corrected during the inspection ("on-the-spot" corrections) are not to be treated as though they were "corrected before inspection." So in both of the above scenarios the facility should be cited (i.e., the noncompliant item not having been identified as a problem by facility personnel with actions taken to permanently correct it, and/or the correction of a noncompliant finding at the time of an inspection).
There is another example when inspectors should cite a facility. This is when there was a noncompliant finding cited during the prior year’s inspection, the facility corrected the problem after that inspection, then the same noncompliance occurred again, and was again corrected by the facility. While this facility has corrected the problem(s), its corrective actions did not result in a permanent fix, and as such, the noncompliance is likely to occur again. In this type of situation, the facility should be cited.
Background:
During the initial stages of the inspection program, FDA recognized that there would be a transition period after October 1, 1994, during which some facility staffs might still not be fully informed of the details of the MQSA requirements. During this period, there was the possibility that even facilities whose staffs believed they were in full compliance with the regulations would actually unknowingly be falling short in one or more areas. It was also possible that as the facility staff became more knowledgeable about the MQSA requirements, they would themselves discover and correct the deficiencies before their first inspection. In fact, FDA received several calls from facilities and inspectors about such situations. The callers wondered if the facilities would or should be penalized for a problem that had existed for some time after October 1, 1994, but had been corrected. In nearly all cases, this situation occurred in the personnel area and involved a staff member who on being found to be unqualified was either given additional training or was no longer used by the facility in the mammography area. FDA realized that if a deficiency was declared in such situations, it would be in the position of telling facilities to correct problems that they had already corrected, perhaps even months earlier. Not only would this not contribute to improving the quality of mammography, but would not recognize facilities that had already taken actions on their own to correct problems. These facilities are not equivalent to those that waited for inspectors to tell them action was needed.
Therefore on May 8, 1995, FDA issued its "corrected-before-inspection" (CBI) policy to the inspectors stating that facilities should not be cited for problems that had existed for some time after October 1, 1994, but had been CBI. Although violations were not to be cited in such situations, inspectors were instructed to indicate that the problem had existed and been corrected in the Remarks section related to each area and during the exit interview to remind the facility staff that the problem should not be allowed to reoccur. This was intended as a basis for more stringent action against facilities that might be tempted to abuse this policy.
On January 2, 1997, this policy was modified to exclude level 1 findings from those findings that have been CBI that would not be cited against the facility. Problems that could result in a Level 1 finding would be cited against the facility, but the Warning Letter to the facility would recognize that the violation(s) were CBI and would address the specific actions expected from the facility for those items.