483
Fluke Biomedical LLCFDA 483 - Fluke Biomedical LLC - January 18, 2024
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Record Details
An FDA inspection of Fluke Biomedical LLC in Everett, WA, identified two significant observations. The firm failed to adequately establish and implement corrective and preventive action procedures, leading to incomplete field action determinations and unaddressed complaints. Additionally, the company lacked documented justifications for not reporting certain correction or removal actions to the FDA.
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ID · 044e7180-9a7f-4119-b55f-88e1765c32f7