Jan

2011

Verichem Laboratories Inc.

Recipient: Verichem Laboratories Inc.
Product: clinical chemistry reference materials for in-vitro diagnostic (IVD) use
Date: 12/16/10

1. Failure to validate the design under defined operating conditions and by using initial production units, lots, batches, or their equivalents, as required by 21 CFR 820.30(g).
b) Your firm failed to perform design validation for the data analysis software used in the Cal Ver EP Evaluator to determine out of specification stability results for Verichem products.

FDA office: New England 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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Verichem Laboratories Inc.

Amy Sellers

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