Grifols Therapeutics LLCApril 1, 2014

FDA 483 - Grifols Therapeutics LLC - April 01, 2014

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Record Details

Grifols Therapeutics Inc. in Clayton, NC, was inspected regarding its plasma fractionation operations. The inspection revealed significant issues including product stability concerns with Albumin, incomplete sterility investigations for Prolastin, inadequate media fill accountability, and poor aseptic practices during filling. Additionally, several facility and equipment maintenance deficiencies were noted, indicating a moderate level of severity.

Company: Grifols Therapeutics LLC
Inspection Date: April 1, 2014
Product Type: Biologics
Office: Office of Biological Products Operations - Division I
Person: Mihaly S. Ligmond (CSO)

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ID · fe4782b9-258b-4f75-953d-f2ca64b7f6eb