Customed Inc.

Customed Inc.
Product: medical devices, including convenience packs for surgical procedures
Date: 1/9/2015

Failure to validate the defined user needs and intended uses of the (b)(4) used as part of the quality system according to an established protocol, as required by 21 CFR 820.70(i). Specifically, your firm implemented (b)(4) to track product inventory (incoming materials, finished/released products and quarantine items), however the software was not validated. In addition, the status of lots of finished products and incoming materials in the warehouse failed to match the (b)(4) system inventory.

Your firm?s response dated August 21, 2014, is not adequate. Your firm initiated CAPA (b)(4) to prepare a software validation protocol, however, you failed to initiate a corrective action to identify and address pertinent quality system and production software that have not been appropriately validated. Further, your firm failed to provide the executed (b)(4) validation protocol and summary report for review.

FDA District Office:San Juan 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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