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•Grifols Biomat, INC•May 11, 2026

FDA 483 - Grifols Biomat, INC - May 11, 2026

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Record Details

Grifols Biomat, INC, a plasmapheresis center in Saint Petersburg, FL, was cited by the FDA for a significant failure to maintain donor records. The inspection revealed that the firm was unable to provide donor records from January 2023 to April 2026, which included adverse reaction investigations for multiple donors. This indicates a serious deficiency in the facility's record-keeping practices.

Company
Grifols Biomat, INC
Inspection Date
May 11, 2026
Product Type
Biologics
Office
Office of Medical Device and Radiological Health Division II
Person
  • Steen N. Graham
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ID · 1cc0e4ba-4e92-4fb8-8e86-e2a15f4aedd0

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