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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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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