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Published by enKap
FDA For Cause Inspection: A Compliance Narrative
From a Fictional Drug Company – Part I
by enKap Subject Matter Expert
FDA received a product complaint and shows up unannounced at this fictional drug
manufacturer one day. This compliance narrative focuses on the interaction between the
Quality Assurance Manager and FDA Investigator throughout the inspection and illustrates how
one fictional company can find itself in regulatory trouble when it doesn’t follow GMP and fails
to have specific written quality system procedures. Many areas are discussed, including:
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Records management
Personnel roles and responsibilities
Reviewing product complaints
211.192 investigations
Product rejections
Validation records
Retesting
Procedures
FDA closeout meeting
EXCERPT BEGINS
Day One
Scene: Lobby of a pharmaceutical company – two individuals; receptionist and FDA
Investigator.
Receptionist: How can I help you?
FDA Investigator: I am Consumer Safety Officer Mason. Here is
my identification (shows I.D.) I am here to conduct an inspection
of the facility. Could you please contact a responsible individual
and let him/her know that I am here?”
Receptionist: I will be happy to do that. Please take a seat and I
will get someone quickly.
Note: The receptionist should be familiar with the procedure for handling an inspection and
who in the company needs to be contacted in this situation.
The QA Manager receives a call from the receptionist.
QA Manager: Thank you, I will be there in no more than five
minutes.
Behind the Scenes: At this point, the QA Manager will inform the appropriate company
personnel that the FDA is at the facility. (Individuals noted in the procedure for FDA inspection
are informed).
When the FDA investigator walks into the facility, several actions are initiated. Key personnel
are alerted to the fact that an FDA inspection is in process. This is not limited to personnel in
the facility only, but also corporate headquarters, including the heads of Legal, Regulatory,
Quality Assurance, Manufacturing and President of the company. Actions taken and individuals
informed is according to a procedure that guides individuals on what should be done during an
FDA inspection of a facility in the corporation. The inspection will be handled by designated
individuals at the specific facility, but key people in the corporation must be kept informed of
the progress and results of the inspection.
Scene: Company lobby where FDA Investigator is seated.
QA Manager: Hello, I am Frank Mead, QA Manager for the facility. We
will need to go to the conference room to discuss the reason for this
inspection.
FDA Investigator: Good to meet you, sir. I am Consumer Officer Mason.
Here is my identification. Let’s go to the conference room, and I will
discuss why I am here.
Scene: Conference room with FDA Investigator and QA Manager.
FDA Investigator: As I am filling out the FD-482 Notice of Inspection, I
need to inform you that I am here for a “For Cause Inspection” relating
to a complaint that was received through the United States
Pharmacopoeia (USP) reporting system. The complaint is specific to
content and uniformity issues dealing with your product Uvorsasid, Lot
numbers 3235 and 3236.
QA Manager: As I accept the 482, can you give me some more details
about the complaints received on those two lots of product?
FDA Investigator: Through the USP reporting system, one of your
customers reported observing thin and underweight tablets in products
that your company sent to them. The customer sent a sample to FDA
and our laboratory found the complaint to be valid. I am here to
investigate how this product was distributed and determine if it passed
a required testing.
QA Manager: I can assure you that we will provide all records and
information that you require to complete your investigation. Where and
how you want to start the inspection?
FDA Investigator: I will want to take a tour of the facility at some point,
but for now, I will want to see all complaints received for this product for
the last six months, any 211.192 investigations for the last six months,
laboratory test results and retained samples for the two lots that are in
question. I will want to see reports on all products rejected in the past six
months, as well as the validation reports for the suspect product specific
to blending and tableting operations. I wish to keep this investigation
limited to the two suspect lots, unless my observations justify an
expanded inspection.
QA Manager: I understand your position. The records will be provided,
and any individuals that you may need to interview will be made
available at your request. If you will excuse me, I will start assembling the
records and inform senior management about the inspection.
EXCERPT ENDS
This excerpt is compliments of the FDA Compliance Learning Community of enKap
(http://www.enkap.com).