# FDA 483 - Cade Medical, Inc. - March 06, 2019

Source: https://www.globalkeysolutions.net/records/483/cade-medical-inc/b77ca971-1060-4e45-a470-631eae3143c5

> FDA 483 for Cade Medical, Inc. on March 06, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cade Medical, Inc.
- Inspection Date: 2019-03-06
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Cade Medical, Inc. in Honolulu, HI, an HCT/P distributor, was cited for significant deficiencies in record-keeping and temperature control during an FDA inspection. Observations included incomplete and missing records for various processes, unrecorded storage temperatures for human tissues, and a lack of periodic review of recorded temperatures to ensure compliance. These issues indicate a failure to maintain adequate control over critical aspects of HCT/P handling and storage.

## Related Officers

- [Lewis K. Antwi](https://www.globalkeysolutions.net/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)

Company: https://www.globalkeysolutions.net/companies/cade-medical-inc/0a671330-fc29-4630-9cf1-c0008cc126f4

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0