Training in Good Manufacturing Practices (GMP) is essential for employees, specialists, and managers in GMP-regulated manufacturing, forming the foundation of a complia

The Maharashtra Food and Drugs Administration (FDA) recently raided Gynoveda Femtech Pvt. Ltd., an Ayurvedic drug manufacturer in Bhiwadi, Thane district, seizing drugs

In September 2024, the U.S. FDA released Revision 2 of the document titled "Control of Nitrosamine Impurities in Human Drugs." This updated guidance supersedes the prev

In January 2024, the FDA inspected Eugia Pharma Specialities Limited in Hyderabad and identified several significant deficiencies, resulting in a Warning Letter on Augu

In November 2023, the US FDA issued a Warning Letter to CARsgen Therapeutics Corporation, a CAR T cell manufacturer, due to Good Manufacturing Practice (GMP) violations

In 2011, the FDA introduced updated guidance on process validation, establishing a life cycle that includes Continued Process Verification (CPV) to assess whether proce

The FDA plans to reclassify hepatitis B virus (HBV) assays from high-risk class III devices to moderate-risk class II, allowing them to use the 510(k) pathway for appro

A recent article in *Nature Medicine* reveals that over 40% of artificial intelligence tools approved by the FDA lack clinical evidence. Researchers from the University

A 2023 EU Commission survey of 39 notified bodies assessed certifications and applications under the Medical Device and In-Vitro Diagnostic Regulations (MDR/IVDR). The

The U.S. Food and Drug Administration (FDA) has released draft guidance outlining detailed instructions for conducting use-related risk analyses (URRAs) for drugs, biol

The US Food and Drug Administration (FDA) issued warning letters to two Chinese nonclinical testing labs—Mid-Link Testing Company Ltd. in Tianjin and Sanitation &

The FDA has issued warning letters to Leel Tech, Natures Pillow, Top Dog Direct, Adventure Innovations, and Shenzhen Moyeah for selling unapproved devices that claim to

Questions often arise about using pharmaceutical equipment for both drug and non-drug production. The FDA has recently reinforced its stance on this issue in a new Warning Letter.

 Ref

FDA Warning Letters offer insight into CGMP regulations, with a recent letter highlighting deficiencies in quality assurance. The letter cited 21 CFR 211.22, focusing o

After inadequate root cause analyses at Intercos Europe S.p.A. in Italy, which led to an FDA Warning Letter in mid-August, another Warning Letter was issued just days l

In August 2024, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to a U.S. manufacturer, Kaylaan LLC, after an inspection uncovered significant viola

The competent authority in Germany (Bezirksregierung Koeln) has issued a new GDP Non-Compliance Report in the EudraGMDP database. A reinspection of a wholesale distribu

The Central government tightened drug manufacturing standards after Indian-made cough syrups were linked to 66 child deaths in Gambia in 2022. Despite this, illegal syr

The FDA has released final guidance on Real-World Data (RWD) as part of its Real-World Evidence (RWE) program. This guidance provides information on using electronic he

 On July 23, the FDA issued a Warning Letter to Omega Tech Labs LLC in Boise, USA, citing several deficiencies:

1. Wri

Intercos Europe S.p.A. in Italy recently received an FDA Warning Letter due to failures in testing incoming raw materials, investigating deviations, and missing data.

Max Chemical Inc., a pharmaceutical OTC product manufacturer in Puerto Rico, received a Warning Letter from the FDA in June due to significant GMP violations. The inspe

 On August 5, the FDA issued a warning letter to LS Promotions Inc. in Hicksville, addressing several CGMP violations. The letter, following the review of the comp

The U.S. FDA issued a Warning Letter on July 11, 2024, to a Jordanian OTC drug manufacturer, Nowrez & Ismail Shukri Company, publicly released on August 13, 2024. T

Attendees of the ECA Conference on Visual Inspection of Parenterals, scheduled for November 6-7, 2024, in Berlin, Germany, will receive the latest edition of the ECA's

The U.S. FDA issued a Warning Letter to Yahon Enterprise Co., Ltd., a Vietnamese drug manufacturer, after a December 2023 inspection revealed significant CGMP violation

In August 2024, the U.S. FDA issued a Warning Letter to Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. following an inspection of their site in December 2023.

CMO (Contract Manufacturing Organization) supplier qualification and contracts are key focus areas during inspections. The FDA recently issued a Warning Letter to Veloc

Starting July 1, 2024, the Australian TGA will implement new regulations for GMP inspections of domestic and international manufacturers of medicinal products, APIs, bi

On May 27, 2024, EU member states adopted groundbreaking regulations to enhance the safety and quality of blood, tissues, and cells in healthcare. The SoHO Regulation a

Optikem International Inc. received a Warning Letter from the FDA for significant issues in aseptic manufacturing and facility conditions. The FDA found the production

The FDA issued a warning to Amco International Manufacturing & Design for continuing to produce and distribute batteries for automated external defibrillators (AEDs

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have issued Warning Letters to five companies—Hippy Mood, Earthly Hemps, Shamro

In January 2024, the FDA conducted an inspection at Jiangsu Hengrui, and the preliminary findings were documented in a Form 483. The FDA criticized Jiangsu Hengrui for

The EU Commission must report to the European Parliament and Council on medicinal product falsification trends within five years of the Falsified Medicines Directive 20

During an inspection of a Korean manufacturer producing OTC sunscreen, Aqualex Co., Ltd., the FDA identified multiple Good Manufacturing Practice (GMP) violations, part

On June 18, 2024, the FDA issued a Warning Letter to Dominican company Laboratorio Magnachem International for CGMP violations, following a November 2023 inspection. Th

On 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

An FDA Warning Letter notifies a company of regulatory violations observed during an inspection, citing specific laws and requiring corrective actions. A recent letter

On 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

The 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

In 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

The World Health Organization (WHO) has updated guidance for national authorities and biomedical labs on managing biological risks.

The U.S. FDA has implemented a new rule mandating certification for medical gases and updating GMP requirements, safety reporting, and labeling. Collaborating with stak

The 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

The World Health Organization (WHO) has issued a global alert regarding falsified semaglutide medications used to treat type 2 diabetes and obesity in several countries

A recent non-compliance statement by the Malta Medicines Authority reveals that Akriti Pharmaceuticals, an Indian company, fails to meet Good Manufacturing Practice (GM

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance for the pharmaceutical industry on pharmacovigilance requirements for human vaccin

A few years ago, following nearly 800 meningitis cases linked to the New England Compounding Center, the FDA intensified scrutiny of compounding facilities, resulting i

The 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

The Norwegian Medical Products Agency issued a recent EU Non-Compliance Report to Everest Organics Limited in India, a manufacturer of Omeprazole, citing 18 deficiencie

On 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

In 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

Cardinal Health received an FDA warning letter on April 24 for selling convenience kits containing piston syringes not FDA authorized. Violations were discovered during

The World Health Organization (WHO) has released a new preliminary guideline outlining considerations for preventing and managing nitrosamine contamination in pharmaceu

In April 2024, the FDA issued a Warning Letter to Jiangsu Meifan Biotechnology Co Ltd, a Chinese OTC drug manufacturer, citing significant Good Manufacturing Practice (

The FDA issued a Warning Letter to FirstCham Co, Ltd., citing violations of CGMP guidelines found during an October 2023 inspection. Key findings include:

24-04-2024

Ethylene and Diethylene Testing - Warning Letter

Higley Industries' drug facility received a Warning Letter from the US Food and Drug Administration (FDA) for significant breaches of Good Manufacturing Pract

In 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

The FDA issues Form 483, listing inspection observations, some of which are posted on their website. Alkem Laboratories Limited, a drug manufacturer

A 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

The warning letter identifies the DxI 9000 Access Immunoassay analyzer instrument system and its assays as the items deemed "adulterated" due to compliance shortcomings

On 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

The FDA issued a Warning Letter to Amman Pharmaceutical Industries, a Jordanian manufacturer, after finding significant violations during an August 2023 inspection. The

In October 2022, Madhu Instruments Private Limited in India received a Warning Letter from the FDA due to unsanitary conditions discovered during an inspection. Issues

Renovo specializes in reprocessing and cleaning medical devices like Depuy Mitek Ablation Wands and Ethicon Bladeless Trocars. While holding multiple 510(k) c

The 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

A recent EU Non-Compliance Report issued by the Maltese Medicines Authority to Cubit Lifesciences in India highlights significant observations, necessitating a detailed

In 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

The 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

The FDA issued a warning letter to Exactech regarding packaging issues with its orthopaedic implants, potentially hastening device degradation. Exactech, a manufacturer

Fresenius 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

On 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

Following an inspection of Saga Lifesciences Limited, an Indian pharmaceutical manufacturer, the Maltese authority issued a non-compliance report. This inspection serve

The 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

The Central Drugs Standard Control Organisation (CDSCO) has issued final regulatory guidelines to streamline sampling procedures and maintain a centralized database. Th

The 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

The Commerce Parliamentary Standing Committee proposed revisions to the Market Access Initiative (MAI) guidelines to support large enterprises and recommended adjusting

We recently covered a Warning Letter issued to a Chinese manufacturer for significant breaches of cGMP regulations concerning finished pharmaceuticals. The U.S. Food an

In 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

The World Health Organization (WHO) has published the 10th edition of the "Quality Assurance of Pharmaceuticals: a Compendium of Guidelines and Related Materials, Volum

The Indian Council of Medical Research (ICMR) has recently issued detailed guidelines titled "Ethical Requirements for Laboratory Validation Testing" to uphold ethical

FDA has updated its guidance on Quality Considerations for Ophthalmic Drug Products in response to recent incidents of microbial contamination and safety recalls. The r

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

The FDA issued a Warning Letter to a pharmaceutical company in Thailand for breaching current Good Manufacturing Practice (CGMP) regulations. The letter cited numerous