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  • #16
    Originally posted by wufan View Post
    While I appreciate the broad interpretation of my analogy @shocka khan:, especially given the thread topic, the truth is that the audit I was referring to was from the FDA and not the IRS. The reason I used this analogy on this topic is because it serves as subjective inference that government is treating industry as criminal interprise, rather than a partnership of checks and balances. I believe this behavior to be wide spread beyond the IRS and the FDA.
    That may also be true, but it still doesn't make any difference whether you are a rich vocal republican or a rich vocal democrat. The thrust of this problem is between the government and your employer, not between you and your employer as some here may have insinuated.

    Incompetent people exist in almost every organization. It's just a fact that more incompetent people exist in larger organizations than smaller ones.

    Without knowing anymore than what was shared here, I cannot say whether your compliance examiner is incompetent or whether he was led to an issue by someone else's complaints.

    Either way, maintain your composure and character and do the best you can to present your case. If they are not ignorant, they should listen to you. If your case makes sense (and your compliance examiner is not incompetent) you should be OK.

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    • #17
      Originally posted by shocka khan View Post
      That may also be true, but it still doesn't make any difference whether you are a rich vocal republican or a rich vocal democrat. The thrust of this problem is between the government and your employer, not between you and your employer as some here may have insinuated.

      Incompetent people exist in almost every organization. It's just a fact that more incompetent people exist in larger organizations than smaller ones.

      Without knowing anymore than what was shared here, I cannot say whether your compliance examiner is incompetent or whether he was led to an issue by someone else's complaints.

      Either way, maintain your composure and character and do the best you can to present your case. If they are not ignorant, they should listen to you. If your case makes sense (and your compliance examiner is not incompetent) you should be OK.
      Except..... On two different occasions, years ago, one with the IRS and my family's business, and another at the company I worked for, the IRS did audits. On both occasions, the audits came out clean. But... the IRS kept digging.

      In the case of my family's business, my mother refused to budge. The IRS kept digging, and digging, and digging. Several times, the auditor pleaded for us to just admit an error, there would be a little fine, and everyone could move on. My mom and dad owned the company and my mom told them flat out, that there were no mistakes, that they had been through everything and there was nothing to find. She refused to give in, told them that she had as much or more time than they did. 15 months later, the IRS gave up. I think my family spent more time fighting than had they just gave in and paid a small fine.

      In the case of the small company I worked for, it was similar, but six months into it, the owners broke down, admitted to "undisclosed, unintentional errors", paid $10,000, just to get this behind them.

      A good friend, whom I hunt with, is a retired OSHA investigator. He will tell you straight up that OSHA inspectors are sent out to bring in revenue. Period. While he is adament that his work was vital for employee safety (it is) he also concedes the most frustrating aspect of his career was that he was expected to bring in revenue. As he often said, if he was inspecting a business, he wasn't leaving until he assessed a fine. He believes that fear of OSHA is what creates voluntary compliance and you can't build fear without always assessing fines.

      Maybe it isn't the same for everyone, but those are my two experiences with the IRS, both were similar. As far as OSHA, abiut the only thing that could be worse, is to be a construction company trying to make a small profit on a project bid and managed by tbe Army Corps of Engineers.
      There are three rules that I live by: never get less than twelve hours sleep; never play cards with a guy who has the same first name as a city; and never get involved with a woman with a tattoo of a dagger on her body. Now you stick to that, and everything else is cream cheese.

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      • #18
        The Bever-Dye Law firm is a very fine firm that more or less specializes in tax law. Quite a few of their lawyers are also CPA's.

        Comment


        • #19
          Originally posted by shocka khan View Post
          That may also be true, but it still doesn't make any difference whether you are a rich vocal republican or a rich vocal democrat. The thrust of this problem is between the government and your employer, not between you and your employer as some here may have insinuated.

          Incompetent people exist in almost every organization. It's just a fact that more incompetent people exist in larger organizations than smaller ones.

          Without knowing anymore than what was shared here, I cannot say whether your compliance examiner is incompetent or whether he was led to an issue by someone else's complaints.

          Either way, maintain your composure and character and do the best you can to present your case. If they are not ignorant, they should listen to you. If your case makes sense (and your compliance examiner is not incompetent) you should be OK.
          It was four auditors over three weeks. That's what they send in every year (although usually it's two weeks). There was no for-cause audit. We presented our case. There is no recourse. When they leave the audit findings are finalized. They will be back next year to assess our corrective actions, which will of course cost us millions of dollars in reformulations and hundreds of thousands in fees; not fines.

          They were intentionally misleading as well. A team of 20 or so people was required to host them, pull records, etc. one day they showed up at 4 am. We all were called to come in early. Later they staged a meeting in our conference room from 8 until 4, not allowing us in, and then began the days audit which lasted until 9. They sent three auditors into my area at one time. They all looked at different stuff and demanded my attention, badgering me to come up with the answers simultaneously. Then the fourth auditor called me back to the conference room to discuss other items. I was accused of intentionally stalling the audit.

          There were no findings in my area.
          Livin the dream

          Comment


          • #20
            Originally posted by wufan View Post
            It was four auditors over three weeks. That's what they send in every year (although usually it's two weeks). There was no for-cause audit. We presented our case. There is no recourse. When they leave the audit findings are finalized. They will be back next year to assess our corrective actions, which will of course cost us millions of dollars in reformulations and hundreds of thousands in fees; not fines.

            They were intentionally misleading as well. A team of 20 or so people was required to host them, pull records, etc. one day they showed up at 4 am. We all were called to come in early. Later they staged a meeting in our conference room from 8 until 4, not allowing us in, and then began the days audit which lasted until 9. They sent three auditors into my area at one time. They all looked at different stuff and demanded my attention, badgering me to come up with the answers simultaneously. Then the fourth auditor called me back to the conference room to discuss other items. I was accused of intentionally stalling the audit.

            There were no findings in my area.
            1. Scope is larger than last year.
            2. Team is larger than last year.
            3. External (i.e. non company) people working off hours without prior permission is a big no-no, IMO. They should have/could have worked from their hotel rooms. What if something was stolen, or sensitive business plans or other information copied? What if they were rummaging through your company records without requesting them from either you or your designee?
            4. Did the team conduct any status meetings? Usually status meetings are conducted where the status of issues is discussed. If they had concerns relative to the pace that you were furnishing artifacts, there should have been a prior discussion.
            5. Sending that many auditors into your area (unless you have 15+ or so employees) is disruptive to your business. If you have an engagement memorandum, please take a look at it and see whether they used language like 'we are not here to be disruptive or interrupt your normal business operations'.
            6. How much time was spent fulfilling requests? I would look at the amount of time and the number of artifacts requested and try to get a feel as to whether the items requested and the time spent fulfilling them created significant additional overhead. I tracked this in the past when I was the project manager (on the company side) of our annual SSAE-16 (that's an audit that you provide to service consumers regarding key controls, testing and results).
            7. You should have the ability to appeal any and all findings or fines.
            8. Unless it was a targeted audit, you would expect that the team would be transparent as to their purpose. Did they deviate from the scope of prior years or did they just stick to their usual script. Also, you might want to look at the audit engagement memorandum. Look for language like 'fair and impartial', 'open communication', and come up with examples where they were not fair and impartial and did not communicate openly with you.
            9. I would draft a complaint letter. I would consider sending (depending on how much of a stink you want to raise about it) it to the FDA IG as well as the audit management team and your congressman (if necessary).

            Comment


            • #21
              Don't know if this helps, but I noted this webpage on a 'Transparency initiative' from the FDA:


              Here's another regarding the FDA appeals process (I don't know whether this applies to you or your company)


              Here's the compliance manual, section VI on page 3: "FDA is authorized at reasonable times to access, inspect, and copy any required records related to the clinical investigation.

              4 a.m. and 9 p.m. are not 'reasonable times'.



              Good luck!

              Comment


              • #22
                Originally posted by MoValley John View Post
                A good friend, whom I hunt with, is a retired OSHA investigator. He will tell you straight up that OSHA inspectors are sent out to bring in revenue. Period. While he is adament that his work was vital for employee safety (it is) he also concedes the most frustrating aspect of his career was that he was expected to bring in revenue. As he often said, if he was inspecting a business, he wasn't leaving until he assessed a fine. He believes that fear of OSHA is what creates voluntary compliance and you can't build fear without always assessing fines.

                Maybe it isn't the same for everyone, but those are my two experiences with the IRS, both were similar. As far as OSHA, abiut the only thing that could be worse, is to be a construction company trying to make a small profit on a project bid and managed by tbe Army Corps of Engineers.
                Perhaps that's the way OSHA works in NE but I have an immediate family member who has worked as an OSHA field inspector for 15 years here in KS and from everything I hear it's done 100% fairly here.
                Shocker fan for life after witnessing my first game in person, the 80-74 win over the #12 Creighton Bluejays at the Kansas Coliseum.

                Comment


                • #23
                  Originally posted by Ta Town Shocker View Post
                  Perhaps that's the way OSHA works in NE but I have an immediate family member who has worked as an OSHA field inspector for 15 years here in KS and from everything I hear it's done 100% fairly here.
                  Could be. My IRS stories are from Chicago, the IRS purportedly works a little differently here. Also, our family business was in trucking, so there are tax codes not only on the IRS level, but state level, too. When you were audited, they brought the whole colonoscopy apparatus.

                  My hunting buddy that retired from OSHA worked in Nebraska, Iowa and South Dakota. They never left a jobsite without finding violations. It was just how it was done. He is very proud of his work, but he really didn't like the fact that they weren't done looking until they found a violation.
                  There are three rules that I live by: never get less than twelve hours sleep; never play cards with a guy who has the same first name as a city; and never get involved with a woman with a tattoo of a dagger on her body. Now you stick to that, and everything else is cream cheese.

                  Comment


                  • #24
                    My $0.02. Mark Ayesh, if he is still practicing. The best class I took at WSU was his, when he was an adjunct prof. Always well prepared, very knowledgeable.

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