Warning Letter: Failed to exercise appropriate controls (ucm 355294)

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Ofni Systems

Additionally, during an audit of the data submitted in support of the [redacted] regarding [redacted] tablets USP [redacted] mg, our investigator requested to review the electronic analytical raw data to compare the values for [redacted] assay and degradation products. However, your firm provided only the printed copies of the raw data because your firm did not have the software program available to view the electronic raw data.
Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

During the inspection, our investigator also identified a backdated QC worksheet in the analytical report of [redacted] API raw material batch [redacted]. When your analyst affixed the related substance and IR weight printouts to the Format for Blank Sheet for Printout (Format No. F2/QCD/F/026-00), he signed and dated this worksheet as July 29, 2011. A second analyst, who reviewed this worksheet, also signed and dated it as July 29, 2011. However, your QA department did not issue this worksheet until July 31, 2011. Your analyst acknowledged during the inspection that he backdated this worksheet on July 31, 2011.

Your response stated that the analyst incorrectly dated the worksheet as July 29, 2011, instead of July 31, 2011, and that there was no intention to deliberately backdate the document. However, your response contradicted your analyst’s backdating admittance during the inspection. In addition, your response did not explain the reviewer’s signature which was also dated July 29, 2011.
Backdating documents is an unacceptable practice and raises doubt about the validity of your firm’s records.
View the original warning letter.


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