News & Insights Search

The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and purchasing, and complaint handling and feedback.

Marty Makary, the Commissioner of the US Food and Drug Administration (FDA), announced a new pilot program promising one-day inspections for low-risk facilities on Wednesday.

The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good manufacturing practice (CGMP) requirements, and one firm that has failed to submit an approved application for premarket approval (PMA).

The US Food and Drug Administration (FDA) recently issued three warning letters to facilities in China, the US, and India for noncompliance with current good manufacturing practices (cGMPs). Additionally, FDA sent an untitled letter was to Incyte for making misleading claims about a product on its website.

Key changes with the QMSR include a greater focus on risk management, a culture of quality, and lifecycle integration. One of the biggest changes, officials said, is that risk is at the center of quality processes

The US Food and Drug Administration (FDA) sent a warning letter on 10 March to Novo Nordisk at its Plainsboro, NJ, site for a raft of postmarketing adverse drug experience (PADE) violations, including failing to report adverse events for patients taking the company's GLP-1 treatments indicated for diabetes and weight management.

Simone Pitts, a pharmaceutical investigator in the Office of Human and Animal Drug Inspectorate (OHADI) at the US Food and Drug Administration (FDA), stated that inadequate oversight of manufacturing operations by the quality control unit (QCU) was the top deviation identified in Form 483 inspection reports for pharmaceutical companies during FY 2024.

The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection. This guidance applies to both domestic and international inspections.

The core mission of the US Food and Drug Administration's (FDA) inspections program, as well as how it prioritizes inspections, has remains unchanged despite recent leadership changes at the agency, said Ivy Sweeney, deputy director of the Office of Human and Animal Drug Inspectorate (OHADI).

The US Food and Drug Administration (FDA) issued warning letters to a medical device manufacturer and a homeopathic drug manufacturer for failing to meet current good manufacturing practices (CGMP) requirements. The agency also cited another device maker for marketing products without authorization and failing to comply with clinical trial requirements.

The generic drug industry told the US Food and Drug Administration (FDA) that it opposes waiving annual facility fees for the first three years for companies that establish manufacturing operations for finished generic drugs or active pharmaceutical ingredients (APIs) in the US during user fee negotiations.

The US Food and Drug Administration (FDA) has issued warning letters to a contract drug maker for failing to meet current good manufacturing practices (CGMP) and a clinical investigator for failing to ensure site staff complied with the clinical investigation plan.