Weekly News · Archive

Weekly brief archive

Every Monday we gather the week's global and Korean regulatory news. Search every card published so far by company, agency, or topic, and narrow by agency, category, product family, or period.

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Vol.11

This week · LIVE

EU declares GMP non-compliance for an Indian sterile site after cleaning validation is rated a critical deficiency

2026-08-31EMAFDAMFDSHealth CanadaISPE

21itemsA20 · B1

Vol.10

FDA classes a Cyclophosphamide for Injection recall as Class I after particulate identified as stainless steel is found in product made by Sunny Pharmtech

2026-08-24FDAEMAWHOMFDSHealth CanadaMHRAISPEECA

26itemsA15 · B11

Vol.9

MFDS suspends all manufacturing for three months and seven days after quality control records were falsified and required test equipment was missing

2026-08-17MHRAFDAEMAMFDSHealth CanadaISPEECA

24itemsA21 · B3

Vol.8

FDA issues a warning letter to Dabur India over data integrity violations including a falsified equipment use log

2026-08-10FDAEMAMFDSHealth CanadaECAISPE

26itemsA15 · B11

Vol.7

MFDS cancels the GMP certificate for solid oral dosage forms after certificates of analysis for 10 raw materials were falsified

2026-08-03FDAPIC/SWHOMFDSHealth CanadaECA

58itemsA20 · B38

Vol.6

A nitrosamine impurity in tramadol preparations pulls products from five Korean firms into recall

2026-07-27FDAEMAMHRAWHOMFDSHealth CanadaISPE

96itemsA48 · B48

Vol.5

MFDS suspends manufacture of a disinfectant solution for three months after it failed the microbial limit test in surveillance sampling

2026-07-20FDAPIC/SEMAMHRAMFDSHealth CanadaECAISPE

69itemsA23 · B46

Vol.4

MFDS suspends manufacture of numerous products and imposes a KRW 69,000,000 surcharge after batch records and certificates of analysis were falsified

2026-07-12FDAMFDSHealth CanadaECA

40itemsA26 · B14

Vol.3

A metal foreign body found in one toothpaste pulls 40 brands made on the same production line into a single recall

2026-07-06FDAECAMFDSHealth Canada

36itemsA29 · B7

Vol.2

Two domestic recalls over the N-nitroso-meglumine impurity cover four telmisartan and linagliptin combination products

2026-06-26FDAECAMFDS

27itemsA23 · B4