Drug master file , FDA

Food and Drug Administration. Cover Form for the Technical Review of Drug Master Files, FDA, Rockville, MD, 1998. 

Values in at least two [laboratory records] were altered. Altered values were written under computer generated values. .. and used in potency calculations. Review of the electronic data confirmed the incorrect values, which were part of your submission to the Drug Master File. [FDA Warning Fetter, 2000]... 

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