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

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

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

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

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

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

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