Radiation-Emitting Products

Documentation and Other Issues Related to Inspection Findings

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Whenever Level 1 findings are found during an inspection, supporting documentation (copies of facility documents) should be collected and forwarded to FDA, when applicable. There are exceptions. Copying of documents would not normally be required when findings are generated from equipment testing during the inspection. Also, when a finding due to the failure by the facility to maintain certain records is found, there would probably be no records to copy. When no medical physicist survey has been conducted, there should be nothing to collect. However, in other areas, such as the quality control records or the personnel records, the noncompliance found may show up while inspecting these records. In these cases, the copies of these records should be collected as evidence to support the finding.

To identify the copies, they should be marked with the facility name, the date of the inspection, the inspection ID number, and inspector's name or initials.

Page Last Updated: 07/11/2014
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