Warning Letter: Lack of spreadsheet control (ucm404316)

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Ofni Systems

Failure to maintain complete data derived from all testing and to ensure compliance with established specifications and standards pertaining to data retention and management.

Your firm did not retain complete raw data from testing performed to ensure the quality of your APIs. Specifically, your firm deleted all electronic raw data supporting your high performance liquid chromatography (HPLC) testing of all API products released to the U.S. market. In addition, your firm failed to retain basic chromatographic information such as injection sequence, instrument method or integration method for the tests. Your firm’s lack of data control causes us to question the reliability of your data.

View the original warning letter.


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