483
Biomat USA IncBiomat USA Inc – FDA 483, Mar 7, 2019
Record Details
An FDA inspection of Bio-Blood Components Inc in Columbus, OH, a source plasma establishment, revealed two significant observations. These included inadequate preparation of phlebotomy sites, leading to concerns about sterility, and a failure to timely submit multiple biological product deviation reports. These issues indicate potential non-compliance with regulations concerning donor safety and reporting requirements.
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