iCRco, Inc.July 1, 2022

FDA 483 - iCRco, Inc. - July 01, 2022

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Record Details

iCRco, Inc., a Class II medical device manufacturer in Goleta, CA, was cited with two observations during an FDA inspection. The inspection revealed deficiencies in the firm's medical device reporting (MDR) procedures, specifically regarding the timely transmission and completeness of reports. Additionally, the firm failed to adequately examine labeling for accuracy, including the establishment of Unique Device Identifiers for its ICR 3600 Image Scanners.

Company: iCRco, Inc.
Inspection Date: July 1, 2022
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Kelvin Cheung

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ID · 86f0a3ad-4065-425e-8a9c-62931bb0ce68