483
Yado Medical IncFDA 483 - Yado Medical Inc - February 11, 2020
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Record Details
An FDA inspection of Yado Medical Inc in Columbia, IL, a tissue storage and distributor, revealed two significant observations. The firm failed to maintain proper temperature records for stored HCT/Ps and lacked documentation for equipment maintenance and calibration, specifically for a freezer used to store tissue. These issues indicate deficiencies in environmental control and quality system documentation.
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ID · 13127f02-7f5f-4abe-a724-9741ac42f16d