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.

Weekly brief archive

FDA issues a Warning Letter to Hanlim Pharm Co., Ltd. in Korea over sterile contamination control and area segregation gaps

The Dutch authority found a hospital pharmacy GMP non-compliant over critical deficiencies including release of an ATMP after a failed sterility test, and suspended a clinical trial.

FDA classified three Class I recalls: epinephrine injection and saline injection for particulate matter, and thyroid tablets for superpotency.

FDA posted two Class I recalls of large volume Baxter infusion solutions after stainless steel and fiberglass particulates were identified.

FDA issues a warning letter to a Bausch & Lomb site over inadequate aseptic processing environmental control

FDA issued three Class I recalls for particulate matter in injectable products — glass particles in a tocilizumab injection, and particulate in Lactated Ringer's and cefazolin frozen premix injections.

FDA issues a Class I recall of a compounded glutathione injection from Victory Medical Center Pharmacy over out-of-specification bacterial endotoxin results

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

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

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

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

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

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

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

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

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

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

New GMP inspection findings, every Monday

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