# FDA 483 - Klockner Of North America - February 27, 2019

Source: https://www.keypedia.com/records/483/klockner-of-north-america/745a38f7-83f2-4e4c-8175-c15a112e706d

> FDA 483 for Klockner Of North America on February 27, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Klockner Of North America
- Inspection Date: 2019-02-27
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Klockner Of North America, a human tissue establishment in Miami, FL, revealed two significant observations. The firm failed to periodically review recorded storage temperatures for human tissue and lacked established written procedures for handling and investigating complaints, with the latter being a repeat observation.

## Related Officers

- [Lura Baquero](https://www.keypedia.com/people/lura-baquero/55dc6eb5-01d5-427e-a3ef-cc6ca35f3837)

Company: https://www.keypedia.com/companies/klockner-of-north-america/feb199c7-0277-4e6d-83c3-dca7bcde5a8a

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6