Are you ready when the FDA shows up at your door?

When was the last time an inspector from the FDA
showed up at your site? While many FDA inspections are scheduled with some
advance notification, there is always a possibility that an inspector from the
Agency could show up at your door any time. Are you prepared?

It is a standard practice to have a Standard
Operating Procedure (SOP) defining what your organization should do when the
FDA (or other government agency) shows up at your site. Some of the areas that
you should consider as part of that procedure should include

• Instructions for the receptionist –

           o Request for identification

           o  Whom to contact – usually the Management Representative

           o   Initiate communication to executives and site that inspectors are on site

o   Communication to the site employees notifying everyone that inspectors are on site

• Designated conference room for the inspector

           o   The conference room should be out of the main flow of traffic or work area

o   Audio visual equipment available

           o   Separate conference rooms set up for multiple inspectors

• Staffing the rooms for the inspection – Each room should be staffed with the following

o   One (1) facilitator – someone at a high enough level within organization to have a

           full understanding of how the Quality System is designed, interrelationships
           between functions, and knowledge of appropriate subject matter experts.

           o   One (1) scribe – this individual should be set up with a computer, taking notes –
           as verbatim as possible – of discussions, questions, and records being
           reviewed. It is very valuable to have this individual connected to the back
           room, so that notes can be visible to the individuals prepping subject matter
           experts and documentation.

           o   One(1) observer – this individual should be on a computer with live chat going on with the

          back  room. While the scribe position is taking notes as verbatim as possible, the observer

           is capturing the mood of the room and inspector while giving a heads up to the
           path the inspector is taking.

• Opening meeting

           o   Participants identified – contact list with phone numbers

           o   Facility and business presentation

While the tasks identified in this blog are common sense, you really have to work through the plan and document how you plan to manage the inspection.  Inevitably, Murphy’s Law will interfere if

you don’t prepare:

• How quickly can you get an opening meeting
  assembled? Do you have some generic material available for the inspectors to
  review while you are getting everything organized?  A binder with the
  annual report, generic product information, etc…
• Do you have back-up resources for your primary
  SME resources? in case the Agency shows up when key players are on vacation? Home
  sick? Traveling to another site?  In one practice inspection, we had to go
  3 layers deep into the SME pool due to the unforeseen absences. 
• If you are responsible for multiple sites, are
  you prepared if the inspector shows up at the site across town or across the
  country?
• Can you identify the SME for products and
  processes?  Are they comfortable explaining the product, process and/or
  CAPA?  Have they had interaction with the Agency in the past?

You should stop and take inventory or your preparedness for an Agency inspection as soon as possible.  If you are new to the organization, ask your Manager or someone to review the plan with you.
Just like an emergency preparedness plan for facility evacuation or weather emergency,
the plan should be practiced and maintained. While you probably have a procedure in place, this is a case where it is critical to practice to help assure a successful outcome.

 About The Author

B. Christine Park is a quality systems consultant with expertise in the
implementation and remediation of sustainable and regulatory compliant quality
systems. She has led the successful implementation of quality systems in large
corporations, as well as small startup companies. Her industry experience and
background supports compliant yet practical, pragmatic quality systems. She can
be contacted at 678-480-5411 and cpark928@mindspring.com

 

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