Company: MedRx Inc.
Product: “Otowizard” and “Vet Digitizer”
Date: 3/1/04

Your firm failed to establish and maintain procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality as required by 21 CFR 820.70(c). There was no electro-static discharge (ESD) procedures or other precautions in effect when electronic circuit boards were being assembled (FDA 483, Item #13).

1-1617 (10/10/03) Otowizard (Hardware and Software failures). Investigations status is shown as being complete, however, investigation states the problem to be unresolved, and a root cause has not been determined.

1-1744 (12/17/03) Otowizard (Hardware & Software failures) Mouse not responding. Report status states the investigation is complete, however, no investigation was documented.

Your firm failed to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met as required by 21 CFR 820.30(a), (b) & (g). There were no design control procedures including: a design and development plan that addresses risk analysis, validation and review for the Otowizard; and the validation of device software is incomplete because the software development plan and software validation protocol are inadequate for the Otowizard (FDA 483, Item #s 4, 5 & 6).

FDA District: Florida 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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