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-
Fall Protection Rescue Requirements: US Law Guide
Disclaimer: This article provides general information about OSHA fall protection rescue requirements and is not legal advice. Requirements may vary based on specific work conditions, industry, and state-level regulations. Consult a qualified safety o
Choosing the Right Fall Protection Strategy
A maintenance supervisor at a food packaging plant is planning a Saturday shutdown task: replacing a worn drive motor on a conveyor system that sits on an elevated steel mezzanine, roughly 9 feet above the production floor. The mezzanine has guard
Fall Protection Awareness: Who Falls and Why
In 2024, 844 US workers died in falls, representing 17 percent of all workplace deaths, according to the National Safety Council. Another 480,000 were injured seriously enough to require time off work. Falls were the second leading cause of workpl
Pharma Failure Investigations: 15 Practice Questions
Failure investigations are one of the most consistently cited areas in FDA pharmaceutical GMP inspections. The rules are not complicated, but applying them correctly under batch-release pressure, with incomplete information and competing organisat
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,
Extreme Driving Conditions: Legal Requirements Guide
Disclaimer: This article provides general information about US federal and state driving laws and is not legal advice. Requirements vary by state, vehicle type, and specific conditions. Consult a qualified legal or regulatory professional for guidanc
Trenching Safety Scenario: A Construction Case Study
It's a Tuesday morning on a residential utility installation job. A crew of four is laying sewer pipe in a trench running along the side of a suburban street. The trench is 7 feet deep and about 4 feet wide. A trench box has been positioned at the