Glossary
Endotoxin
Also writtenbacterial endotoxin
A lipopolysaccharide component of the cell wall of Gram-negative bacteria which, if present in a medicine, can cause a pyrogenic response.
Source · EU GMP Annex 1 (2022), Glossary, Endotoxin; MFDS, 「알기 쉬운 GMP 용어집」 Korean original
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Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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You stated in your response that the revised endotoxin test procedure includes the use of single use containers.
FDA · FDA Warning Letter · 2023-06-13 -
Additionally, your validation for umbilical cord processing only included sterility testing and endotoxin testing as measurements of product attributes.
FDA · FDA Warning Letter · 2022-08-09 -
Your response to observation #5 states you sent out current Active Pharmaceutical Ingredient (API) for microbial and endotoxin testing.
FDA · FDA Warning Letter · 2025-04-15
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
EU GMP Annex 1 (2022), Glossary, Endotoxin; MFDS, 「알기 쉬운 GMP 용어집」 Korean originalGRM Regulatory Glossary
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