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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Fixer Retention Analysis Records

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Discussion:

An inspection reminder: FDA does not require facilities to retain the film(s) used for the fixer retention test(s). Since this test is based on a color comparison of the area where the fixer and the test chemical are applied to the film and since these areas change in color with time, the usefulness of these test films is limited to a relatively short period of time following the performance of the test.

For the fixer retention test, FDA requires the facility to keep records of the performance of the test (and any corrective action taken) since the last inspection or for the past three tests, whichever is longer.