Warning letters, 483s, Recalls, Import Alerts, Audit observations
In October 2024, Accord Healthcare recalled over 25 lots of Cinacalcet tablets in various strengths
FDA has issued an Updated Guidance for Control of Nitrosamines in Human Drugs in September
Glenmark recalled several lots of Rizatriptan Benzoate Tablets and Rizatriptan Benzoate Orally Disintegrating Tablets in
EMA(Europeans Medicines Agency) has updated the Appendix 1 Acceptable intakes established for N-nitrosamines with 15
European Pharmacopoeia Commission (EPC) approved the new strategy for N-nitrosamine impurities in individual monographs in
Lupin recalled 3 batches of Desloratadine tablets in Dec 2023 for N-Nitroso Desloratadine impurity exceeding
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
