Nitrosamines: USFDA issues guidance on R
USFDA: Recommended Acceptable Intake Limits for Nitrosamine Drug Substance[1]Related Impurities (NDSRIs) – Guidance for Industry
Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA: Recommended Acceptable Intake Limits for Nitrosamine Drug Substance[1]Related Impurities (NDSRIs) – Guidance for Industry