Failure to maintain complete data from all laboratory tests as required by 21 CFR 211.94 (a). There is no back-up file for laboratory UV spectrophotometer test results for some tests. The spectrophotometer does not automatically back-up data and the analyst is required to assign an identification number to each individual chromatogram in order for it to be saved. In some cases, original data was lost and the tests had to be performed again to determine final distribution of the lots.
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