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CFR 21 Part 111 Dietary Supplements and the "screening of employees"


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Plastic Ducky

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Posted 10 April 2020 - 08:36 PM

Hello everybody out there!!!

 

There is a discussion going on here at work about an attribute of Part 111 and Food Defense.

 

Part 111 states that "All employees shall be screened prior to employment".

 

Some are saying that means they all have to do a criminal back ground check.

Some are saying the the term "screened" implies they should all be subject to a drug screen.

 

I don't know that is the truth because it doesn't state criminal background check directly, or drug screen directly, I believe there is wiggle room in there to "screen" employees in some other fashion like simply subjecting there social security number to verification as a matter of employment. But maybe I am wrong.

 

Please share your experience and/or understanding of this federal regulation and I will send intense, unscientifically validated Anti-COVID19 -VIBES- in your direction regardless of where you are in the world.....

 

Sincerely,

 

Plastic Ducky



SQFconsultant

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Posted 10 April 2020 - 10:07 PM

Yes, very vague.

 

We decided to do a full crime/sex offender check and drug test prior to employment, then again I guess we could have sat the person down in a room with a screen between us during the interview and that would suffice for this super vague thing. Oh, I got the visual.

 

I will admit that I liked the screening process of one of my clients from years ago - he asked me if I wanted to sit in on an interview and I said sure.

 

He said that he likes to "screen" all the new people -- off the top of my head these were the questions (and yes, I know this is all not legal.)

 

So, how old are you?

Are you married?

Do you drink?

Smoke pot?

Do you like to drive fast?

Will you take $XXXXXX a week?

 

Yes, I sat there horrified --- and then laughed a lot later on!


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Posted 11 April 2020 - 01:29 PM

Not so familiar with the dietary supplements world (or indeed the US CFR in general, for that matter), but the attached draft FDA guidance from the food side of things does at least provide a bit of discussion on employee screening - see the Personnel and Operations-Based Mitigation Strategies section starting on page 70.

I've no idea how consistently the FDA is likely to apply this across to supplements but it's hopefully a starting point at least. 

This looks at screening very much in terms of background/credit checks, references etc.



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