Warning Letter: No documentation of employee training (s6597c)

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Ofni Systems

Failure to ensure that all personnel are trained to adequately perform their assigned responsibilities; and failure to implement your training procedure, as required by 21 CFR §820.25(b). For example, there is no documentation of any training of any current employees with regard to their assigned responsibilities, although your training procedures require documentation of training. … Failure to conduct quality audits; and failure to implement audit procedures to assure that the quality system is in compliance with the established quality systems requirements and to determine the effectiveness of the Quality Systems, as required by 21 CFR § 820.22.

View the original warning letter.


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