Glossary
Depyrogenation
A process that removes or inactivates pyrogens on product contact surfaces or materials to a defined level.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your firm failed to validate your (b)(4) to ensure it can maintain adequate temperatures to achieve required depyrogenation.
FDA · FDA Warning Letter · 2021-04-27 -
Your firm uses a <Redacted B4> for the depyrogenation of glassware in the production of sterile, injectable drug products.
FDA · FDA 483 · 2024-01-17 -
Your firm uses a <Redacted B4> for the depyrogenation of glassware used in the production of sterile, injectable drug products.
FDA · FDA 483 · 2024-01-17
