FDA Warning Letter & 483 Remediation

Resolving agency deficiencies can be one of the most complicated programs to effectively manage. Firms must rapidly implement effective interim controls, while not excessively burdening their processes to the point that you create new bottlenecks, and ultimately more deficiencies. They must also implement long term solutions that effectively balance quality improvement with cost realities. It is easy to just add more control steps without analyzing the risk and benefit to the actions.


Time To Improve Your Business?

At the same time, remediation is a great time to improve organizational efficiency. A firm may typically take many weeks to properly process a change. When you are faced with hundreds or even thousands of procedures requiring revision, you can either lean out your process or apply an army of people to a process not designed for remediation.

For one client, we expanded detail to the master remediation schedule to cover activities from all of the groups required to restart multiple buildings and multiple production lines. The schedule covered everything from engineering projects and work to utility systems, to environmental monitoring and production scheduling. It included updates required and resource loading for documentation such as change control, SOP and drawing updates and CAPAs. From this detailed schedule, it was then possible to determine where resources were going to be needed, such as spikes in the amount of documentation required and timing for when utilities would be needed to support production test runs and validations.
Remediation is a time when some people rise to the challenge and some find a place to hide from the storm. We implement communication procedures to ensure that companies are aligned on their goals and are communicating effectively across a large number of people and interconnected work.

We are experienced in remediation

We have worked with multiple clients though remediation to see the light at the end of the tunnel, confirm it is not a train coming … and made it successfully to the other side.