Warning Letter: Failure to establish adequate procedures(ucm271368)

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Ofni Systems

Failure to establish adequate procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example, testing records for timers received on March 27, 2009; April 9, 2009; April 17, 2009; and May 28, 2009, only included a computer printout of the final data as the original raw data of the testing conducted and acceptance data for each of the timers were not maintained.

View the original warning letter.


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