Grifols Therapeutics LLCSeptember 1, 2023

FDA 483 - Grifols Therapeutics LLC - September 01, 2023

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Record Details

An FDA inspection of Grifols Therapeutics LLC in Clayton, NC, identified several significant deficiencies in their biologic drug manufacturing operations. Key issues included inadequate control over production processes, failures in equipment preventive maintenance, and a lack of established written procedures for critical tasks. Additionally, the facility exhibited poor maintenance of freezers and insufficient control of utility support systems.

Company: Grifols Therapeutics LLC
Inspection Date: September 1, 2023
Product Type: Biologics
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Yonggang Wang (investigator)
Kula Jha, Ph.D.
Bradley Dworsak

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ID · a0027827-e11c-4401-8d9e-736ea37fded6