WASHINGTON, D.C. — On Wednesday, the Food and Drug Administration (FDA) released a draft guidance for industry detailing processes and practices for inspections under its Bioresearch Monitoring ...

including Good Manufacturing Practice (GMP), Bioresearch Monitoring (BIMO), and 503B outsourcing facility inspections. Although participation in a remote evaluation will be voluntary, the guidance ...

ORA will focus more on conducting investigations, inspections, and oversight of imports, still operating through offices for medical devices, human & animal drugs, biologics, and bioresearch ...

With some 8000 site inspections of drug manufacturing facilities postponed ... of drug manufacturing, compounding, and bioresearch monitoring facilities, a process that FDA compliance offices plan to ...

The on-site inspection was conducted from 3rd March, 2025 to 7th March, 2025, by investigators from Bioresearch Monitoring Programme (BIMO) and Office of Study Integrity & Surveillance (OSIS) of US ...

820.30 "Design Controls.”FDA will not inspect design controls during bioresearch monitoring inspections. The concept of an environmental management system evolved in the early nineties and its origin ...

Inspectors told the Government Accountability Office (GAO) that the FDA’s Bioresearch Monitoring program is ... reported that the FDA conducted 537 inspections in 2022, a 45% decline from ...