Day

December 6, 2000
06
Dec

Active Pharmaceutical Ingredients (APIs)

December 6, 2000
Societa Italiana Mediciniali Scandicci 12/6/00 APIs …The computer systems used to control and/or monitor production, reconcile raw materials, assign batch numbers, and control solvents, have not been validated. The validation of the computer system used to control the … process is incomplete…. We have also reviewed your November 3, 2000 written response to the FDA-483…...
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