Glossary
Pyrogen
A substance that can cause a febrile reaction when administered to humans or animals.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Pyrogen; EU GMP Annex 1 Glossary Korean original
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 conduct laboratory testing to determine whether each batch of drug product purporting to be sterile and pyrogen-free conforms to such requirements (21 CFR 211.167(a)).
FDA · FDA Warning Letter · 2023-08-08 -
Your firm failed to clean and sterilize and process, where indicated by the nature of the drug, container closures to remove pyrogenic properties to assure they are suitable for their intended use (21 CFR 211.94(c)).
FDA · FDA Warning Letter · 2021-11-16 -
Your firm failed to conduct appropriate laboratory testing to determine whether each batch of drug product purporting to be sterile and pyrogen-free conforms to such requirements (21 CFR 211.167(a)).
FDA · FDA Warning Letter · 2025-05-20
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
MFDS, 「알기 쉬운 GMP 용어집」, Pyrogen; EU GMP Annex 1 Glossary Korean originalGRM Regulatory Glossary
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