23-07-2024 FDA Warning Letter issued to a Manufacturer of an Athlete Muscle Maintenance CrèmeOn July 9, the FDA issued a Warning Letter to South Korean manufacturer reBom Co., Ltd. for non-compliance with CGMP standards. The letter cites issues found in respons |
23-07-2024 FDA outlines detailed CAPA Procedure in Warning LetterAn FDA Warning Letter notifies a company of regulatory violations observed during an inspection, citing specific laws and requiring corrective actions. A recent letter |
23-07-2024 FDA Warning Letter issued to Chinese OTC Manufacturer for Lack of Analytical Test DataOn July 8, 2024, the FDA issued a Warning Letter to YangZhou SuXiang Medical Instrument Co., Ltd., a Chinese OTC drug manufacturer. The letter, based on a review of the |
20-07-2024 GDP Non-Compliance Report for Czech Wholesale DistributorThe State Institute for Drug Control in Czechia has published its first GDP Non-Compliance Report for 2024 in the EudraGMDP database. Dated June 27, 2024, the report fo |
19-07-2024 FDA Warning Letter issued due to Missing incoming Control TestsIn June 2024, the U.S. FDA issued a Warning Letter to Portuguese company Fancystage Unipessoal, LDA, following a January 2024 inspection. The letter highlights serious |
06-07-2024 World Health Organization releases updated laboratory biosecurity guidanceThe World Health Organization (WHO) has updated guidance for national authorities and biomedical labs on managing biological risks.
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03-07-2024 FDA publishes Final Rule on Medical GasesThe U.S. FDA has implemented a new rule mandating certification for medical gases and updating GMP requirements, safety reporting, and labeling. Collaborating with stak |
01-07-2024 FDA Warning Letter: GMP Requirements also applicable to HPLC Analyses for Internal UseThe U.S. Food and Drug Administration (FDA) issued a Warning Letter to GFA Production Xiamen Co., Ltd., a Chinese drug manufacturing facility, for significant CGMP viol |
22-06-2024 World Health Organization releases warning on falsified medicines used for diabetes treatment and weight lossThe World Health Organization (WHO) has issued a global alert regarding falsified semaglutide medications used to treat type 2 diabetes and obesity in several countries |
12-06-2024 GMP Problems with critical Medicinal Products - what next?A recent non-compliance statement by the Malta Medicines Authority reveals that Akriti Pharmaceuticals, an Indian company, fails to meet Good Manufacturing Practice (GM |
07-06-2024 CDSCO publishes new draft guidance on pharmacovigilance requirements for vaccinesThe Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance for the pharmaceutical industry on pharmacovigilance requirements for human vaccin |
05-06-2024 Handling of Microbiological Deviations and Sterility Testing - FDA issues Warning LetterA few years ago, following nearly 800 meningitis cases linked to the New England Compounding Center, the FDA intensified scrutiny of compounding facilities, resulting i |
29-05-2024 FDA issued a Warning Letter to Contract Testing Laboratory in Uruguay following Data Integrity ViolationsThe FDA issued a Warning Letter on April 30, 2024, to a Montevideo-based contract testing lab following a November 20-22, 2023 inspection. Violations of Current Good Ma |
15-05-2024 FDA Warning Letter with multiple Deviations to a Korean CompanyOn April 16, the FDA issued another Warning Letter to Korean manufacturer C&T Dream Co., Ltd. regarding their production of over-the-counter topical medicines, foll |
15-05-2024 Lack of Quality Oversight: EU Non-Compliance Report issued to Omeprazole ManufacturerThe Norwegian Medical Products Agency issued a recent EU Non-Compliance Report to Everest Organics Limited in India, a manufacturer of Omeprazole, citing 18 deficiencie |
08-05-2024 Cardinal receives FDA warning letter because of unapproved syringesCardinal Health received an FDA warning letter on April 24 for selling convenience kits containing piston syringes not FDA authorized. Violations were discovered during |
08-05-2024 FDA Warning Letter: Missing Identification TestsIn March 2024, Master Paints & Chemicals Corp. received a Warning Letter from the U.S. FDA following an inspection in October 2023. The letter outlined significant |
02-05-2024 WHO: Draft for the Prevention and Control of Nitrosamine ContaminationThe World Health Organization (WHO) has released a new preliminary guideline outlining considerations for preventing and managing nitrosamine contamination in pharmaceu |
30-04-2024 Warning letter issued to South Korea - from process validation to analysis of starting and raw materialsThe FDA issued a Warning Letter to FirstCham Co, Ltd., citing violations of CGMP guidelines found during an October 2023 inspection. Key findings include:
FDA issued a Warning Letter to a Biotechnology Company in ChinaIn April 2024, the FDA issued a Warning Letter to Jiangsu Meifan Biotechnology Co Ltd, a Chinese OTC drug manufacturer, citing significant Good Manufacturing Practice ( |
24-04-2024 Missing Ongoing Stability Studies for APIs : FDA Warning LetterIn April 2024, the U.S. FDA issued a Warning Letter concerning Antaria Pty. Ltd., an Australian company, following an inspection conducted in November 2023. The |
24-04-2024 Ethylene and Diethylene Testing - Warning LetterHigley Industries' drug facility received a Warning Letter from the US Food and Drug Administration (FDA) for significant breaches of Good Manufacturing Pract |
22-04-2024 FDA Form 483 mentions 10 Observations made during an Inspection of an Indian Drug ManufacturerThe FDA issues Form 483, listing inspection observations, some of which are posted on their website. Alkem Laboratories Limited, a drug manufacturer |
15-04-2024 FDA issues Warning Letter to Canadian OTC ManufacturerA Canadian OTC drug manufacturer received a Warning Letter from the U.S. FDA for significant violations of CGMP regulations. The firm produces hand sanitizer gel and bu |
09-04-2024 Beckman Coulter receives FDA warning letterThe warning letter identifies the DxI 9000 Access Immunoassay analyzer instrument system and its assays as the items deemed "adulterated" due to compliance shortcomings |
03-04-2024 Warning Letter issued to Chinese OTC Manufacturer: Violations of Current Good Manufacturing Practice (CGMP) regulationsOn March 26, 2024, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to a Chinese manufacturer operating a U.S.-registered facility, known for produci |
03-04-2024 Inadequate Equipment and Facility DesignThe FDA issued a Warning Letter to Amman Pharmaceutical Industries, a Jordanian manufacturer, after finding significant violations during an August 2023 inspection. The |
31-03-2024 Indian Sterile Facility in a Dilapidated ConditionIn October 2022, Madhu Instruments Private Limited in India received a Warning Letter from the FDA due to unsanitary conditions discovered during an inspection. Issues |
29-03-2024 FDA issued a warning letter for reprocessed medical devices: RenovoRenovo specializes in reprocessing and cleaning medical devices like Depuy Mitek Ablation Wands and Ethicon Bladeless Trocars. While holding multiple 510(k) c |
25-03-2024 EU Non-Compliance Report issued after insufficient CAPAA recent EU Non-Compliance Report issued by the Maltese Medicines Authority to Cubit Lifesciences in India highlights significant observations, necessitating a detailed |
25-03-2024 FDA Warning Letter to Drug Manufacturing Facility in ThailandThe U.S. Food and Drug Administration (FDA) issued a Warning Letter on February 27, 2024, to a drug manufacturing facility in Thailand for serious violations of Current |
21-03-2024 FDA sends three warning letters in probe of plastic syringes made in ChinaIn late 2023, the FDA commenced evaluating plastic syringes from China for quality issues, advising against their use due to reported problems. Warning letters were issued to Medline Industries and |
15-03-2024 EMA/FDA joint Q&As on Quality and GMP aspects of Breakthrough Therapy ApplicationsThe FDA and the European Medicines Agency (EMA) have jointly published "EMA–FDA joint Q&As on Quality and GMP aspects," aiming to support quality enhancement |
15-03-2024 Exactech drilled with a warning letter over implant packagingThe FDA issued a warning letter to Exactech regarding packaging issues with its orthopaedic implants, potentially hastening device degradation. Exactech, a manufacturer |
15-03-2024 FDA warning letter over issues at ex-Ivenix site: Fresenius KabiFresenius Kabi received a warning letter related to large-volume infusion pumps acquired through its $240 million takeover of Ivenix. The FDA cited delays in completing |
09-03-2024 FDA Warning Letter on unapproved and misbranded DrugsOn February 7, 2024, the FDA issued a Warning Letter to a company based in the United States, US Chem Labs. The letter addresses the marketing and distribution of |
06-03-2024 Non-compliance Report (EudraGMDP): Cross-Contamination Risk at Indian Pharmaceutical CompanyFollowing an inspection of Saga Lifesciences Limited, an Indian pharmaceutical manufacturer, the Maltese authority issued a non-compliance report. This inspection serve |
22-02-2024 Telangana and Goa regulators qualified to observe US FDA inspections in IndiaThe US Food and Drug Administration (FDA) announced that Goa and Telangana's regulatory bodies can now observe inspections conducted by the FDA in India. These states j |
20-02-2024 Parliamentary Panel advises revision of MAI, PLI strategies to boost pharma exportsThe Commerce Parliamentary Standing Committee proposed revisions to the Market Access Initiative (MAI) guidelines to support large enterprises and recommended adjusting |
20-02-2024 KMIO framing complete state childhood cancer policy to place it as a national guidelineThe Kidwai Memorial Institute of Oncology (KMIO) in Karnataka is crafting a comprehensive childhood cancer policy for the state, aspiring to set a national standard for |
20-02-2024 CDSCO issues regulatory policies for sampling of drugs, cosmetics and medical devicesThe Central Drugs Standard Control Organisation (CDSCO) has issued final regulatory guidelines to streamline sampling procedures and maintain a centralized database. Th |
19-02-2024 A new FDA Warning Letter for Chinese Company after the Review of RecordsWe recently covered a Warning Letter issued to a Chinese manufacturer for significant breaches of cGMP regulations concerning finished pharmaceuticals. The U.S. Food an |
14-02-2024 FDA Warning Letter states about observation of particulates in repackaged drug componentsIn January 2024, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Glicerinas Industriales, S.A. de C.V., a Mexican company, following a May 2023 i |
09-02-2024 WHO: Updated Edition of the GMP Compendium for Medical ProductsThe World Health Organization (WHO) has published the 10th edition of the "Quality Assurance of Pharmaceuticals: a Compendium of Guidelines and Related Materials, Volum |
09-02-2024 ICMR issues extensive guidance on ethical prerequisites for laboratory validation testingThe Indian Council of Medical Research (ICMR) has recently issued detailed guidelines titled "Ethical Requirements for Laboratory Validation Testing" to uphold ethical |
08-02-2024 FDA Revision to the Guidelines on Quality Considerations for Ophthalmic Drug ProductsFDA has updated its guidance on Quality Considerations for Ophthalmic Drug Products in response to recent incidents of microbial contamination and safety recalls. The r |
07-02-2024 New FDA Warning Letter for inadequate Quality OversightThe FDA issued a Warning Letter to a pharmaceutical company in Thailand for breaching current Good Manufacturing Practice (CGMP) regulations. The letter cited numerous |
07-02-2024 India's Health Ministry modifies GMP Rules - and replaces the 'GMP' Term.The Indian pharmaceutical industry, a major exporter of generic drugs, faces scrutiny for occasional lapses in quality. In response, the Ministry of Health has issued r |
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