Warning Letter: Failure to comply(g1120d)

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Ofni Systems
 
References validation and lab documentation - "...requires that all drugs be manufactured, processed, packed, and held according to current good manufacturing practice. No distinction is made between active pharmaceutical ingredients and finished pharmaceuticals, and failure of either to comply with CGMP constitutes a failure to
comply with the requirements
of the Act...."s."

View the original warning letter.


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