Radiation-Emitting Products

Use of Claimed or C

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As of March 1, 2001, inspectors will no longer be able to use the Claimed "C" option. In the case where a facility is unable, at the time of the inspection, to supply proper documentation of meeting a requirement but claims to have such documentation, the inspector should:

  1. Leave the item blank. The inspection software will include this item in the missing data report.

  2. The inspector should delay uploading the inspection for up to 5 business days. If the facility supplies the proper documentation, the inspection should be revised accordingly, uploaded to FDA as usual, and a printed post inspection report should be provided to the facility. If the facility does not supply the proper documentation within 5 business days, the inspection question(s) should be answered "NO". The inspection should then be uploaded to FDA as usual, and a printed post inspection report with the new non-compliance should be provided to the facility.

Note: In those cases where the facility’s inability to provide the necessary documentation within the 5 day period is beyond the facility’s control, the inspector should contact the Inspector HelpDesk for further instructions.

Note:

The above policy only mentioned documentation related to the personnel area. Inspectors may use the Claimed data for the survey report that is claimed by the facility. For claimed survey reports, the same procedure should be followed as for personnel documentation.

Page Last Updated: 08/11/2014
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