Cardinal Enterprises – Part 11

Company: Cardinal Enterprises Inc.

Date: 12/07/2001
Product: Drug products

Master production and control records are not prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated and signed by a second person. Master production records are generated from a computer as electronic records without any apparent controls to assure authenticity and integrity [21 CFR 211.186(a)-Form FDA Observation 21].

FDA District: New England District Office

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.

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