Active Pharmaceutical Ingredients (APIs)

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…
Your proposed corrective actions for deficiencies 2, 3, and 4 regarding validations appear satisfactory except that the validations will not be completed until the end of March, 2001 and imply that you would continue to use the unvalidated computer systems and equipment cleaning methods until then.

SoftwareCPR Keywords: Human Drugs

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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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