Supplier Quality Inadequate

Warning Letter: Failure to record in audit trail (ucm076260)

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On January 11, 2006, during content uniformity testing of[redacted], the analyst noticed that the first two capsules were out-of-specification

and the run was aborted. The audit trail for the laboratory data acquisition system does not indicate that the run was aborted and the analyst did not print the sample results or record the failing results in the laboratory notebook.

View the original warning letter.