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

Source: https://www.keypedia.com/records/483/cade-medical-inc/d53fbab8-ef1d-4be1-bc4c-50f655e0a16a

> FDA 483 for Cade Medical, Inc. on September 18, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cade Medical, Inc.
- Inspection Date: 2019-09-18
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Officers

- [Compliance Officer at FDA](https://www.keypedia.com/people/lauren-m-lilly/41582ad0-67b1-4c60-99e2-c1e3c63811c2)

Company: https://www.keypedia.com/companies/cade-medical-inc/8a004c19-2a5b-4944-b2ca-14a037b04a44

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6
