The Enterey Blog

Why Inspection Management Systems Matter

Posted by Tita Tavares on Wed, Dec 28, 2011 @ 12:01 PM

There are many reasons why it is important for companies to develop and implement an effective inspection management system. In this blog, we’ll outline some of the reasons and how having an effective inspection system can benefit your bottom line.

Since FDA Commissioner Margaret A. Hamburg’s arrival in 2009, the FDA and other regulatory agencies have noticeably raised the bar on measures they are willing to take to protect patients’ safety. In her well-publicized speech of 2009 to the Food and Drug Law Institute entitled, "Effective Enforcement and Benefits to Public Health," Hamburg outlined measures being implemented to make the FDA stronger, more credible to the public, and more vigilant in their role of inspecting companies to ensure compliance. Her remarks included her desire for the Agency to take fast, effective actions when a company was non-compliant with the regulations.  As a result, the following actions have occurred at FDA:

  1. More Inspections: In 2011, more FDA inspectors were sent out in the field performing more inspections (particularly overseas).
  2. More/ Quicker Warning Letters: Companies no longer receive multiple warning letters like they did under previous administrations.  FDA is much more willing to take significant action after just one “poor” inspection.
  3. Elimination of Mandatory Legal Reviews: In doing so, the FDA has increased the speed of issuing warning letters while giving Districts more control over the tone and language of the letters.
  4. Post-Inspection Deadlines: Companies have 15 working days to respond to any problems that have been identified on the FDA 483 if they want to mitigate a possible Warning Letter.

 Why Inspection Management Gold

Increase in Consent Decrees: The FDA appears to be much more willing to use this Agency’s resource-intensive legal tool to get a company’s attention.  These actions are very expensive for both the Company and FDA; the willingness of the Agency to use this tool demonstrates their commitment to increase enforcement.


Willingness to Entertain Misdemeanor Prosecutions: At the 2010 FDLI Annual Conference, Eric Blumberg, FDA deputy chief for litigation in the Office of the Chief Counsel, heralded the reemergence of the Park Doctrine as part of FDA's new enforcement efforts. The Park doctrine allows the government to seek misdemeanor convictions against company officials for alleged violations of the FDCA – even if the officials were unaware of the violations – if they were in positions of authority to prevent or correct violations and did not.


A Good IMS Equals Good Business:

Implementing an inspection management system on an ongoing basis, 24/7, 365 days a year is just good business.  A well-functioning inspection management system is really a “work prioritization and resource allocation” tool designed to allow you to remain current in your compliance with appropriate laws and regulations.  With the multitude of areas that require maintenance, an effective system will help you rank your risks by criticality so that you can address your most urgent weaknesses and continually eliminate problems and issues.


A good IMS System:

  1. Allows you to self-identify and fully understand your compliance gaps.
  2. Allows you to prioritize work and allocate resources to close those gaps.
  3. Allows you to track gaps, actions taken, and assess residual risk.
  4. Helps fulfill the compliance requirements of ICH Q10 by helping to keep senior management informed about your state of compliance.
  5. Maintains an inspection-ready posture at all times so when the FDA inspector arrives unannounced, you are ready.
  6. Allows you to respond to Agency findings systemically and quickly.


Enterey, in partnership with Mark Tucker, LLC, offers a customized approach to help companies develop and implement an inspection management system that will help you meet these criteria. We will talk to you about what you have and need. Then, depending on your needs, we will help you develop an appropriate system and train your staff on implementation. Our training will allow you the ability to implement your new system, so that you can seamlessly interact with the Agency during and after an inspection.


What if a “Bad” Inspection Takes Place?

In the event of a bad inspection, we can help you prepare your response; including helping you understand if and where your inspection system failed.  Ultimately, your goal is to eliminate all gaps. If you invest upfront in preventative maintenance of your Quality system, you may avoid large expenditures on emergencies or reacting to regulatory agencies as you eliminate sources of error.   And when a significant issue does arise, you will be knowledgeable about the issue and able to present it to the FDA knowing you have done a good, documented investigation.  


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Published by Mark Tucker | Partner of Enterey


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Next special article blog:
Agency Inspections are on the Rise.

Tags: Enterey, FDA, 483 FDA Warning Letter, Inspection Management, Inspection Readiness, Inspection Management Systems, IMS, Mark Tucker

The Importance of Scheduling Facility Maintenance Shutdowns

Posted by Tita Tavares on Fri, Dec 09, 2011 @ 11:30 AM

We’re all aware that we need to perform periodic recommended maintenance on our vehicles, such as oil changes for our cars every 3000 miles. What’s the worst that can happen if we skip these?  A potentially hefty repair bill at the mechanic shop if not caught in good time, or the worst case scenario – the annoyance of a breakdown on the side of the road.

 Facility Shut Down  

Similar to our cars, manufacturing facilities require periodic maintenance.  Most facilities are shutdown every 6-18 months to perform preventative maintenance or repair tasks on facility and utility systems.  What’s the worst that can happen if these are skipped?  There’s probably no significant damage to systems if caught in relatively short time.  But despite the low risk, there is a possibility of failure of equipment and systems when operating outside of the manufacturers’ recommended maintenance intervals.  These repairs can cost a significant amount of money, cause facility downtime, and most importantly potential contamination or loss of product. Most importantly, it will also require a resource draining assessment of the impact to manufacturing processes and products.  

Knowing this, the U.S. Food and Drug Administration requires that facilities and equipment be maintained and kept in good repair in 21 Code of Federal Regulations (CFR) Part 110.  One manufacturer, a pharmaceutical manufacturing facility in North Carolina, who ignored this warning learned the hard way when in November of 2007, they underwent an inspection by the FDA.  The inspector found environmental monitoring excursions in the purified water loop dating back to February and March of 2007 – eight months earlier. 

While the company noted that a modification to the purified water loop would correct the problem, the necessary parts had not been ordered or installed.  In fact, the company waited until June 2008, during the plant’s semi-annual plant maintenance shutdown, to install it.  In the meantime, production was compromised by this and other issues which they failed to address or rectify.

As a result of this and other significant violations, the FDA issued a warning letter and advised the company to take prompt action to correct all deviations. Failure to do so would result in regulatory action including seizure and/or injunction.

Had this company taken the necessary steps to schedule the maintenance and modification of their purified water loop during their annual or semi-annual plant maintenance shutdowns, they could have identified issues causing the environmental excursions, then successfully taken corrective action.  Their inspection would have gone smoother and they could have avoided receiving the dreaded “483 - FDA Warning Letter” and the prospect of fines, penalties and expensive repairs.

Most importantly, they would not have compromised their manufacturing facility with potential contaminants which could lead to risks for patients, loss of contracts, the destruction of inventory, and a public relations nightmare.

By scheduling periodic facility maintenance shutdowns, complete preventative maintenance designed to improve equipment life can be performed along with any modifications and system updates.  With the appropriate time afforded for a shutdown, operations can be expected to run at the greatest efficiency, eliminating or minimizing the need for unplanned facility downtime.

To ensure the longevity of your operations, schedule your facility maintenance shutdowns. You’ll sleep better knowing that all systems are on track.


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Published by Murtaza Kapadia | Senior Manager, Enterey


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Next week’s blog:
A Look at What Happens Behind the Scenes of a Plant Maintenance Shutdown


Tags: 483 FDA Warning Letter, Corrective Action, Facility Maintenance Shutdowns, Facility Maintenance, Regulatory