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483
•CSL Plasma Inc.•July 12, 2024

FDA 483 - CSL Plasma Inc. - July 12, 2024

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Record Details

CSL Plasma Inc. in Saginaw, MI, received a Form 483 following an inspection from July 9-12, 2024. The inspection revealed significant insanitary conditions, including widespread insect infestation with dead and alive beetles in multiple rooms and structural deficiencies like air gaps. These findings indicate a failure to maintain clean and orderly facilities, raising concerns about product integrity and safety.

Company
CSL Plasma Inc.
Inspection Date
July 12, 2024
Product Type
Biologics
Office
Division of Pharmaceutical Quality Operations III
Person
  • Gabryelle J. Solverud
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ID · 60648ac5-3982-4093-901d-53d940363b58

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