Cade Medical, Inc.September 18, 2019

FDA 483 - Cade Medical, Inc. - September 18, 2019

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Record Details

Cade Medical, Inc., an HCT/Ps storage and distributor in Temecula, CA, was cited for deficiencies in its record-keeping practices. The inspection revealed that records for the receipt, distribution, and temperature monitoring of tissue products consistently failed to identify the individuals performing these critical activities. This lack of personnel identification resulted in incomplete historical documentation for various operational processes.

Company: Cade Medical, Inc.
Inspection Date: September 18, 2019
Product Type: Biologics
Office: Division of Pharmaceutical Quality Operations IV
Person: Lauren M. Lilly (Compliance Officer at FDA)

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ID · d53fbab8-ef1d-4be1-bc4c-50f655e0a16a