Klockner Of North AmericaFebruary 27, 2019

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

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Record Details

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.

Company: Klockner Of North America
Inspection Date: February 27, 2019
Product Type: Biologics
Office: Office of Medical Device and Radiological Health Division II
Person: Lura Baquero

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ID · 745a38f7-83f2-4e4c-8175-c15a112e706d