Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

I experienced my first FDA Inspection, and I would like some feedback on how Inspectors typically conduct themselves during these activities. 

I was surprised at the Inspector's behavior because of rude comments being made about employee names, asking about age of employees, and make condescending comments suggesting that employees were not competent.  Furthermore, the inspector was making inappropriate comments about the device itself.

Is this type of behavior typical?  Have others received similar treatment or comments from an inspector?  Is there anything that can be done about this type of treatment?

This message was posted by a user wishing to remain anonymous

In thirty years of being inspected, I've never encountered unprofessional behavior like that from FDA or PHS. It's definitely not in line with their current statement of core values, including diversity, equity, inclusion, and respect.

Depending on circumstances, I'd probably respond with a chilly stare and a flat, "we don't speak to one another that way" or "not funny - we take patient care seriously".  Of course that isn't always possible, depending on age, size, gender, and so on...

If you're acquainted with the division lead, you might drop a hint that this one could do with some re-education. Or if it's truly egregious, a formal complaint is possible.

Original Message:
Sent: 30-May-2023 12:14
From: Anonymous Member
Subject: FDA Inspector Conduct

This message was posted by a user wishing to remain anonymous

Hello,

I experienced my first FDA Inspection, and I would like some feedback on how Inspectors typically conduct themselves during these activities.

I was surprised at the Inspector's behavior because of rude comments being made about employee names, asking about age of employees, and make condescending comments suggesting that employees were not competent.  Furthermore, the inspector was making inappropriate comments about the device itself.

Is this type of behavior typical?  Have others received similar treatment or comments from an inspector?  Is there anything that can be done about this type of treatment?

This message was posted by a user wishing to remain anonymous

On the other hand, if the violations are so egregious I would not be surprised with that behavior! We really do not know the actual situation so all the comments that you are likely to see may agree with your assessment! At the same time there is another side to the coin which we really do not know other than you!

Original Message:
Sent: 30-May-2023 12:14
From: Anonymous Member
Subject: FDA Inspector Conduct

This message was posted by a user wishing to remain anonymous

Hello,

I experienced my first FDA Inspection, and I would like some feedback on how Inspectors typically conduct themselves during these activities.

I was surprised at the Inspector's behavior because of rude comments being made about employee names, asking about age of employees, and make condescending comments suggesting that employees were not competent.  Furthermore, the inspector was making inappropriate comments about the device itself.

Is this type of behavior typical?  Have others received similar treatment or comments from an inspector?  Is there anything that can be done about this type of treatment?

Anon,

Without being there and seeing the circumstances, sometimes it does happen.  People are people.  And not all people are nice people.  Whether they are just not a nice person or going through something currently in their life ... there is still an ethical code of conduct in professional situations.  If the investigator was egregious in their conduct toward you or the company employees, report this to the local US FDA district office.  I have had to do this on a couple occasions and the local office do take any complaints seriously.  (They are government paid employees and do not want "marks" on their tenure.)

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 30-May-2023 16:36
From: Anonymous Member
Subject: FDA Inspector Conduct

This message was posted by a user wishing to remain anonymous

On the other hand, if the violations are so egregious I would not be surprised with that behavior! We really do not know the actual situation so all the comments that you are likely to see may agree with your assessment! At the same time there is another side to the coin which we really do not know other than you!

Original Message:
Sent: 30-May-2023 12:14
From: Anonymous Member
Subject: FDA Inspector Conduct

This message was posted by a user wishing to remain anonymous

Hello,

I experienced my first FDA Inspection, and I would like some feedback on how Inspectors typically conduct themselves during these activities.

I was surprised at the Inspector's behavior because of rude comments being made about employee names, asking about age of employees, and make condescending comments suggesting that employees were not competent.  Furthermore, the inspector was making inappropriate comments about the device itself.

Is this type of behavior typical?  Have others received similar treatment or comments from an inspector?  Is there anything that can be done about this type of treatment?

Please contact the US FDA Office of Ombudsman to file a complaint about the rude behavior of the FDA inspector.  The FDA Office of Regulatory Affairs (ORA) Ombudsman Program (OOP) enhances ORA operations by serving as an objective, neutral resource to improve communication channels, facilitates dispute resolutions, and fosters positive relationships with internal and external stakeholders.   Out of curiosity, is the FDA inspector from the Office of Pharmaceutical Quality (OPQ) or the Bioresearch Monitoring (BIMO) Operations?  These are two separate organizations within the US FDA that conduct GxP inspections. OPQ conducts cGMP inspections while GLP, GCP, and GVP inspections are conducted by BIMO. 

------------------------------
Aldwin Aldana
Director, Clinical Quality Assurance (GCP)
West Newton MA
United States
------------------------------

Original Message:
Sent: 30-May-2023 12:14
From: Anonymous Member
Subject: FDA Inspector Conduct

This message was posted by a user wishing to remain anonymous

Hello,

I experienced my first FDA Inspection, and I would like some feedback on how Inspectors typically conduct themselves during these activities.

I was surprised at the Inspector's behavior because of rude comments being made about employee names, asking about age of employees, and make condescending comments suggesting that employees were not competent.  Furthermore, the inspector was making inappropriate comments about the device itself.

Is this type of behavior typical?  Have others received similar treatment or comments from an inspector?  Is there anything that can be done about this type of treatment?