https://grm-solutions.com/en/ A weekly roundup of global and Korean pharmaceutical GMP and quality regulatory news, written in English. Sourced from public releases by the FDA, EMA, MFDS, Health Canada and other agencies. en Mon, 31 Aug 2026 07:30:00 +0900 https://grm-solutions.com/en/briefs/2026-08-31/ https://grm-solutions.com/en/briefs/2026-08-31/ Mon, 31 Aug 2026 07:30:00 +0900 EU declares GMP non-compliance for an Indian sterile site after cleaning validation is rated a critical deficiency · Health Canada issues Type I recalls for two herbal liquids found to contain the undeclared prescription ingredient sildenafil · MFDS imposes a KRW 19,350,000 surcharge after manufacturing steps were not recorded at the time the work was done https://grm-solutions.com/en/briefs/2026-08-24/ https://grm-solutions.com/en/briefs/2026-08-24/ Mon, 24 Aug 2026 07:30:00 +0900 FDA classes a Cyclophosphamide for Injection recall as Class I after particulate identified as stainless steel is found in product made by Sunny Pharmtech · Health Canada recalls B. Braun Lactated Ringer's Injection USP as Type I after particulate matter is found · MFDS recall covers three repaglinide products after N-nitroso-melumine is detected above the limit https://grm-solutions.com/en/briefs/2026-08-17/ https://grm-solutions.com/en/briefs/2026-08-17/ Mon, 17 Aug 2026 07:30:00 +0900 MFDS suspends all manufacturing for three months and seven days after quality control records were falsified and required test equipment was missing · MHRA issues a GMP non-compliance statement to NORGINE LIMITED over critical PQS and QP batch release deficiencies, suspending human medicine certificates in part and IMP certificates in full · FDA issues five Form 483 observations at Alvotech's biologics site covering complaint handling, aseptic process validation and environmental monitoring https://grm-solutions.com/en/briefs/2026-08-10/ https://grm-solutions.com/en/briefs/2026-08-10/ Mon, 10 Aug 2026 07:30:00 +0900 FDA issues a warning letter to Dabur India over data integrity violations including a falsified equipment use log · Rohto-Mentholatum in Vietnam recalls eight eye drop products for lack of assurance of sterility · MFDS suspends manufacture of a herbal product for three months after ash and acid-insoluble ash failed specification https://grm-solutions.com/en/briefs/2026-08-03/ https://grm-solutions.com/en/briefs/2026-08-03/ Mon, 03 Aug 2026 07:30:00 +0900 MFDS cancels the GMP certificate for solid oral dosage forms after certificates of analysis for 10 raw materials were falsified · FDA issues seven Form 483 observations at the Wizcure Pharmaa sterile site, including no personnel, surface or active air monitoring at all · A doxorubicin hydrochloride injection is recalled voluntarily over concern about a packaging defect found in distribution https://grm-solutions.com/en/briefs/2026-07-27/ https://grm-solutions.com/en/briefs/2026-07-27/ Mon, 27 Jul 2026 07:30:00 +0900 A nitrosamine impurity in tramadol preparations pulls products from five Korean firms into recall · MFDS imposes a KRW 227,850,000 surcharge after certificates of analysis were recorded as passing before testing was complete · Italy's AIFA declares GMP non-compliance at Avlab over critical and structural deficiencies in the aseptic compounding quality system https://grm-solutions.com/en/briefs/2026-07-20/ https://grm-solutions.com/en/briefs/2026-07-20/ Mon, 20 Jul 2026 07:30:00 +0900 MFDS suspends manufacture of a disinfectant solution for three months after it failed the microbial limit test in surveillance sampling · Recalls over the N-nitroso-meglumine impurity spread across linagliptin and metformin combination products from several Korean firms · FDA lists a recall of 10 CareFusion ChloraPrep and PurPrep applicator products distributed before sterilisation https://grm-solutions.com/en/briefs/2026-07-12/ https://grm-solutions.com/en/briefs/2026-07-12/ Sun, 12 Jul 2026 07:30:00 +0900 MFDS suspends manufacture of numerous products and imposes a KRW 69,000,000 surcharge after batch records and certificates of analysis were falsified · FDA classes four products including BD ChloraPrep Clear as Class II recalls for lack of sterility assurance caused by a packaging seal defect · MFDS orders a mandatory recall of a herbal product after the heavy metal cadmium was detected https://grm-solutions.com/en/briefs/2026-07-06/ https://grm-solutions.com/en/briefs/2026-07-06/ Mon, 06 Jul 2026 07:30:00 +0900 A metal foreign body found in one toothpaste pulls 40 brands made on the same production line into a single recall · Botulinum toxin made for export only was sold domestically without national lot release, triggering a recall and sales suspension · A linagliptin and metformin extended-release tablet is recalled at two strengths over the N-nitroso-meglumine impurity https://grm-solutions.com/en/briefs/2026-06-26/ https://grm-solutions.com/en/briefs/2026-06-26/ Fri, 26 Jun 2026 07:30:00 +0900 Two domestic recalls over the N-nitroso-meglumine impurity cover four telmisartan and linagliptin combination products · FDA classes a doxorubicin hydrochloride liposome injection recall as Class I after particulate identified as glass is found · FDA issues a CGMP warning letter to Huons Co., Ltd. in Korea, confirming enforcement reaching a Korean finished product site