483
Grifols Therapeutics LLCFDA 483 - Grifols Therapeutics LLC
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Record Details
Grifols Therapeutics LLC, a biologic drug manufacturer in Clayton, North Carolina, was cited for significant deficiencies in its aseptic processing procedures. The inspection revealed inadequate documentation for media fill reconciliation and a lack of periodic review for filling line intrusions. Additionally, the firm's bioburden monitoring for pre-sterile bulks was found to be inadequate, with issues in speciation and investigation of microbial findings.
- Company
- Grifols Therapeutics LLC
- Product Type
- Biologics
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ID · 9b3fca0f-5880-4793-ac91-143400fc36bf