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483
•Ionisos S.A.S.•April 2, 2024

FDA 483 - Ionisos S.A.S. - April 02, 2024

Record Details

IONISOS, a contract sterilizer in Sable-sur-Sarthe, France, was inspected by the FDA from April 2 to May 2024. The inspection revealed deficiencies primarily concerning process validation activities and supplier qualification. Specifically, the firm failed to adequately validate processes and qualify suppliers for critical services.

Company
Ionisos S.A.S.
Inspection date
April 2, 2024
Product type
other
Office
International Compliance Team
Person
  • Stephen D. Eich (investigator)
View Company Profile

ID · 8569c325-54e3-4704-bfb5-04a0107733f5

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