Warning Letter: Failure to maintain complete data (ucm527005)

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Ofni Systems

Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.

Our investigators observed systemic data manipulation across your facility. They documented unexplained deletions of laboratory test results. They discovered that you repeated tests until you obtained acceptable results and that you failed to investigate out-of-specification or otherwise undesirable test results. Your firm relied on these falsified and manipulated test results to support batch release and stability data. Your firm routinely re-tested high performance liquid chromatography (HPLC) samples and deleted previous chromatograms without justification. Your management acknowledged that employees in your quality control laboratory have access, authority, and the ability to delete and repeat HPLC injections when undesirable results were encountered prior to reporting final results.

Your response states repeated testing was due to quality control operators continuously injecting solvents until a stable baseline was achieved. The response also states the results of repeated tests were deleted to decrease the number of saved chromatograms on your hard drives. Any data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria and maintained for CGMP purposes. In order to exclude data from the release criteria decision-making process, you must have valid, documented, scientific justification for its exclusion.

Reducing the number of records on your hard drives is not a sufficient justification for excluding data. Your response is inadequate because you have not shown how you will correct the data manipulation and falsification practices discussed above, nor have you demonstrated how you will ensure that all CGMP test results are retained and considered by your quality unit as a part of batch release…

On November 16, 2015, you told our investigators that you had stopped manufacturing [redacted] API in September 2015. However, during our inspection, our investigators reviewed HPLC and gas chromatogram electronic audit trails that indicated you conducted multiple HPLC and GC analyses on [redacted] batches of [redacted] API from November 5 to 6, 2015 (batch numbers [redacted] to [redacted]).

View the original warning letter.


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