Warning Letter: Firm not reporting all electronic results obtained (ucm 361553)

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Ofni Systems

We observed and documented practices during the inspection that kept some samples, data and results outside of the local systems for assessing quality. This raises serious concerns regarding the integrity and reliability of the data generated at your Kalyani plant. For example,

a. Our review of the Chromeleon and Empower II software found that your firm was testing samples unofficially, and not reporting all results obtained. Specifically, “test,” “trial” and “demo” injections of intermediate and final API samples were performed, prior to performing the tests that would be reported as the final QC results.

b. Out-of-specification or undesirable results were ignored and not investigated.

c. Samples were retested without a record of the reason for the retest or an investigation. Only passing results were considered valid, and were used to release batches of APIs intended for US distribution.

d. Unacceptable practices in the management of electronic data were also noted. The management of electronic data permitted unauthorized changes, as digital computer folders and files could be easily altered or deleted.

View the original warning letter.


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