Warning Letter: Failure to maintain complete data (ucm 543347)

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Ofni Systems

Our investigators reviewed audit trails from various stand-alone pieces of laboratory equipment you used to perform high performance liquid chromatography (HPLC) and gas chromatography (GC) analyses.  Our investigators found that you had deleted entire chromatographic sequences and individual injections from your stand-alone computers.

For example, your written system suitability procedure for [redacted] requires only six injections. However, your records showed that on January 5, 2016, you injected seven system suitability standards when performing system suitability for batch [redacted].  The audit trail showed that the final standard injection was permanently deleted from the instrument’s computer.  Your analyst told our investigator that it is laboratory practice to perform more injections than are required by the procedure, and then delete any undesirable result to ensure passing system suitability results.

Without providing scientific justification, you repeated analyses until you obtained acceptable results.  You failed to investigate original out-of-specification or otherwise undesirable test results, and you only documented passing test results in logbooks and preparation notebooks.  You relied on these manipulated test results and incomplete records to support batch release decisions.

View the original warning letter.


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