Warning Letter: Failure to validate computer system (s7045c)

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Ofni Systems

Failure to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess [21 CFR § 211.100(a)]. For example, your firm’s automated packaging line processes and their respective software systems have not been validated .

View the original warning letter.


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