Sep

2004

Guardian Drug Co. Inc.

Company:Guardian Drug Co. Inc.
Product:Infant Gas Relief Drops, Nausea Contorl Cherry Liquid, Gastro Bismuth Liquid and other drugs
Date: 9/15/04

Regarding Observation 15, your response indicates that the computer software was initially validated in April 2001 and that it was going to be revalidated in May 2004. You also included the validation report of the software used for maintenance of the complaint. However, the adequacy of the challenges to the computer systems cannot be fully assessed since the validation protocols were not provided.

FDA District: New Jersey District Office

About the author

Amy Sellers

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.

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Guardian Drug Co. Inc.

Amy Sellers

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