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483
•Klockner Of North America•February 27, 2019

Klockner Of North America – FDA 483, Feb 27, 2019

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
View Company Profile

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

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