FDA Inspections and Enforcement Archives

Medical device reporting guide graphic showing reporting roles for device users, healthcare facilities, importers, manufacturers, and regulatory authorities under FDA 21 CFR Part 803, with a reporting checklist covering serious incidents, vigilance reporting, post-market surveillance, and timelines

September 2, 2026

by VelSafe Editorial Team Guides

21 CFR Part 803: Medical Device Reporting Requirements

EU MDR 2017/745 regulation book beside a stethoscope and compliance checklist showing key principles including safety, transparency, accountability and continuous improvement, with a laptop displaying an MDR overview, representing the scope and general provisions of the EU Medical Device Regulation

September 2, 2026

by VelSafe Editorial Team Insights

EU MDR 2017/745: What Articles 1 and 2 Mean for Compliance

Cleanroom operator reviewing production batch record with QSR and QMSR seven subsystem compliance checklist and February 2026 regulatory update badge

August 10, 2026

by VelSafe Editorial Team Worker Safety

QSR: What Every Medical Device Worker Needs to Know

GMP compliance manager standing calmly in a pharmaceutical boardroom with FDA inspection interview technique tip cards overlaid

August 9, 2026

by VelSafe Editorial Team Tips

10 FDA Inspection Interviewing Techniques

Import operations other activities guide featured image showing a male import compliance professional in a high-visibility vest reviewing documents at a US Customs and Border Protection workstation with a CBP officer in the background, and a panel showing bonded warehouses, foreign trade zones, duty drawback, CTPAT, prior disclosure, and focused assessment compliance tools.

August 4, 2026

by VelSafe Editorial Team Guides

Import Operations: Bonded Warehouses, FTZ, and CTPAT

GUIDE: Import Operations Import Operations: Other Activities, Programmes, and Compliance Tools Beyond the basic customs entry process, US import operations involve a range of specialist programmes, legal tools, and compliance activities that

The US import process insights featured image showing a container ship and truck at a commercial port with a six-stage import journey diagram covering pre-arrival ISF filing, transport, customs entry, CBP examination, agency clearance for FDA and OSHA compliance, and release and delivery, alongside a multi-agency compliance panel showing CBP, FDA, and OSHA logos.

August 4, 2026

by VelSafe Editorial Team Insights

The US Import Process: How Goods Enter US Commerce

INSIGHTS: Import Operations The US Import Process: How Goods Move from Foreign Supplier to US Commerce Understanding the import process means understanding a sequence of regulatory checkpoints, documentation requirements, and agency interacti

Import operations legal background and regulatory framework featured image showing a container ship at a commercial port with an Import shipping container on a truck, an Import Compliance checklist covering customs entry, regulatory approval, product safety, documentation, and recordkeeping, and a Law book.

August 4, 2026

by VelSafe Editorial Team Law

Import Operations: Legal Background and Regulatory Framework

LAW: Import Operations Import Operations: Legal Background and Regulatory Framework Every product that crosses a US border enters a layered regulatory system involving Customs and Border Protection, the Food and Drug Administration, the Consu