Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA: Recommended Acceptable Intake Limits for Nitrosamine Drug Substance[1]Related Impurities (NDSRIs) – Guidance for Industry
EMA updates Q&A document on N-Nitrosamines. In the Rev 16 (dated 7 July 2023) limits
USFDA Warning letter to Dupont cites inadequate OOS investigations, Root cause and CAPA, Impact evaluation. The warning letter
In September 2022, USFDA issued a Warning letter to Lupin API facility at Tarapur, India
USFDA Warning letter to Mylan in 2020 cited inadequacy of cleaning, cleaning procedures, risk assessment of
IPEC Federation announced the availability of the “Questionnaire for Excipient Nitrosamines Risk Evaluation” (version 1,
