Online Safety Community

FDA inspection is not going to invite an FDA action such as a 483 or a Warning Letter

If there is one common cause for apprehension between the smallest and biggest, and the best known and least known organizations; it has to be an FDA inspection! Any organization that is subject to an FDA inspection has to get absolutely everything of everything about its activities right to a T, to such an extent that it should be sure simply all the time, through all its processes, that an FDA inspection is not going to invite an FDA action such as a 483 or a Warning Letter. This means compliance at its highest and lowest levels.


To simplify matters to an extent, the FDA has tried to be of some assistance to help in monitoring the conduct of all aspects of the conduct and reporting of organizations involved in FDA-regulated research. This has concretized in the form of the FDA’s Bioresearch Monitoring Program, or BIMO. This on-site inspection and data audit program can be used as a reference guide by industries in FDA-regulated research industries. Adherence to it is a yardstick for compliance with FDA regulations in the field.

In other words,compliance to the implementation requirements of the BIMO is a fair indicator of how well the organization comes out unscathed out of an FDA inspection. Meant for monitoring Clinical Investigators (CIs), the Institutional Review Boards (IRBs), Sponsors or Contract Research Organizations (CROs)/Monitors, and nonclinical laboratories; the BIMO spans quite a range of players in the FDA-regulated research.

What are the BIMO’s objectives?

The FDA’s Bioresearch Monitoring Program has two important objectives:

  • Protecting the welfare, rights and safety of human research subjects
  • Ensuring that the data collected by researchers is reliable and is of acceptable integrity and quality

The-Pros-and-Cons-of-Biologics-for-UC-1440x810 150w, 300w, 722w" sizes="(max-width: 490px) 100vw, 490px" width="490" height="275" />

What are the BIMO’s functions?

The FDA’s Bioresearch Monitoring Program has a few functions, which research organizations that have to survive an FDA inspection could do well to comprehend. These include:

  • Clinical data auditing
  • Inspection of the ongoing clinical research
  • Subjecting nonclinical laboratories and IRBs to inspections
  • Taking steps to train, educate and implement the FDA’s Application Integrity Policy.

Understand the underlying causes that lead to an inspection

The key to passing an FDA inspection is to understand that there are strong reaons for which an FDA inspection happens. Research organizations that want to pass an FDA inspection have to get a grasp of the factors that prompt the FDA to inspect research. These include:

  • Introduction of a new technology
  • Introduction of a new product or an indication
  • Receipts of complaints by the FDA from aggrieved parties
  • CRO being a habitual non-complier

Views: 18


You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Jam Blanco posted a blog post

Appropriate Safety Masks to Use to Avoid Inhaling Asbestos

Workers from practically all trades, from factory workers to roofers, carpenters, auto mechanics, plumbers, and others are in danger of being exposed to asbestos on the job. Studies prove that individuals…See More
9 hours ago
Adam Fleaming posted a blog post

Virtual healthcare has to be understood and used for what it can offer

Among the many offshoots of the growth of technology; virtual healthcare is a very recent and important development. In simple language, virtual healthcare, a term easy enough to understand, is the use of technologies that enable remote consultation and monitoring of healthcare.Putting technologies to remote use has been in use for a while now, what with corporate entities carrying out conferences and virtual conferences at the push of a button. Virtual technology has also been in widespread…See More
15 hours ago
Mark Nilson posted events
16 hours ago
John Robinson posted events
17 hours ago


Understanding Data Parallelism in MapReduce

In order to understand the goals of MapReduce, it is important to realize for which scenarios MapReduce is optimized. The MapReduce programming model is created for processing data which requires…Continue

Tags: program, Implementation, Mapreduce

Started by gracylayla Mar 14.

Automation Anywhere. How do I pick a value from dropdown

Automation Anywhere. How do I pick a value from dropdown. I tried 'set text' from a copied variable. Its very slow, and also doesnt…Continue

Tags: anywhere, automation

Started by emmablisa Mar 9.

TensorFlow serving vs TensorFlow service

I have a question regarding the difference between TensorFlow Serving versus TensorFlow service. (Sorry that I'm not familiar with this at all.)I found TensorFlow serving's definition, which is "…Continue

Tags: training, online, tensorflow

Started by emmablisa Feb 27.

Proper maintenance for Hi Vis clothing

Can you tell me how to properly take care of Hi Vis jackets? I recently purchased a few ones from this…Continue

Started by Lily Osborn Feb 25.

Forklift Operator Requirements 1 Reply

At our company we have a lot of forklift traffic that has to share the same aisles as our pedestrians. We limit the speed of our lifts to 3 mph.  I am wanting to find out what requirements for…Continue

Started by Rick Briggs. Last reply by Tony Ferraro Feb 25.



© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service