483
Stony Brook University Medical CenterStony Brook University Medical Center – FDA 483, Mar 14, 2019
Record Details
An FDA inspection of Stony Brook University Medical Center's Blood Bank revealed two significant observations. The facility failed to consistently follow its written standard operating procedures for blood collection, specifically regarding skin preparation drying times. Additionally, the inspection found a failure to maintain adequate records for the inspection of returned blood products and for the proper operation and maintenance of blood specimen analyzers.
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