All FDA-regulated products imported into the United States must meet the same laws and regulations as domestic goods. There is no lower standard for imported products. A food product manufactured in another country and offered for import at a US p
First Aid Awareness: A Workplace Guide
First aid awareness is not the same as first aid training. Awareness gives employees the knowledge to recognize that an emergency is happening, understand what the immediate response should be, know when and how to call for help, and take basic pr
Burns and Electrical Shock First Aid: A Workplace Guide
Burn injuries and electrical shock are among the most common serious injuries in construction and general industry. The Electrical Safety Foundation International reports 5,180 nonfatal electrical injuries involving days away from work in 2023-202
First Aid for Medical Emergencies: A Workplace Guide
Medical emergencies do not announce themselves. A worker in a warehouse has chest pain. A colleague on a construction site becomes unresponsive. Someone in an office collapses during a meeting. In each case, the first few minutes of response by wh
Fire Prevention in the Workplace: A Complete Guide
Introduction In 2024, US fire departments responded to an estimated 1,388,000 fires, causing 3,920 civilian deaths, 11,780 civilian injuries, and $19 billion in direct property damage. Manufacturing and industrial properties were consistently
Financial Disclosure by Clinical Investigators Guide
When a sponsor submits a marketing application to the FDA, the agency does not evaluate the clinical data in isolation. It considers who conducted the studies and whether any financial relationships between those investigators and the sponsor coul
FDA Establishment Inspections: A Complete Guide
An FDA establishment inspection (EI) is a careful, critical, official examination of a facility to determine its compliance with laws enforced by the FDA. For any pharmaceutical manufacturer, medical device maker, biologics producer, or other FDA-
Failure Investigations for Medical Device Makers
Failure investigations are the point at which a medical device manufacturer's quality system either demonstrates genuine effectiveness or reveals its limitations. They are among the most consistently cited areas in FDA medical device inspections,
European Vigilance for Medical Devices: Full Guide
Vigilance is the cornerstone of post-market safety oversight for medical devices in the European Union. Under Medical Device Regulation (MDR) No. 2017/745 and In Vitro Diagnostic Regulation (IVDR) No. 2017/746, manufacturers are legally required t
Calibration Program Essentials for Cosmetics Makers
Cosmetics manufacturing depends heavily on accuracy. From ingredient measurements to environmental controls, every step affects product safety, quality, and regulatory compliance. A strong calibration program helps maintain reliable measurements, pre