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FDA Facility Registration (Inspection)


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#1 Aliaime

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Posted 07 January 2015 - 09:46 AM

Hello all,

 

I was trying to look how to get the facility registration done, and I found  the guidance for industry in the FDA website said "FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act".  

 

There are few questions I want to ask for help:

  • Is FDA going to inspect the company during the registration?
  • what if my company is oversea?
  • what are they going to inspect? 
  • It said the registration is fee of charge, what about the travel fee for inspection?
  • If I already have the login to create P/N, does that mean I have done the facility registration already?

 

I am kinda confused about the inspection.  Hopefully someone could explain this.  Thanks.


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#2 MWidra

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Posted 07 January 2015 - 04:56 PM

Hi Aliaime:

 

The FDA is allowed to inspect any food manufacturing facility that is registered with them.   Our facility is inspected 2 times a year and the state of Maryland performs the inspection for the FDA.  We are not charged for this, it is not like a third party audit.  They just show up.  If your product is considered a high risk product, your inspection may be more rigorous than one for a low risk product, as I understand it.  Some of that will depend on if your product requires you to have a HACCP plan or not, by FDA rules.

 

Here is a link to a 2011 webinar on foreign inspections from the FDA site.  It may give you more information.

 

http://www.fda.gov/a...s/ucm254903.htm

 

Martha


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#3 RG3

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Posted 07 January 2015 - 05:49 PM

Hello Aliaime,

If you have a login doesn't mean you have been registered. If you're registered you would be given a Food Facility Registration Number at https://www.access.fda.gov. There is also an option to search your company once you log in. You can ask for a confirmation copy to register your facility with the FDA as required by 21 CFR Part 1, Subpart H, and the public Health Security and Bioterrorism Preparedness and Response Act of 2002 by emailing fis@fda.gov or calling the FDA Industry Systems Help Desk via telephone 301-575-0156. AFAIK there needs to be an initial inspection. After that they are announced as a frequency of their discretion.


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#4 RG3

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Posted 07 January 2015 - 05:59 PM

FDA does a very general food safety inspection at least here in the states. They'll ask you what different products you do, how many employees, how many shifts, how big the facility is, how long you've been in business,  HACCP, GMP's, building condition, environmental program - corrective actions, any kind of micro results, they'll take samples of your packaging especially if it has an allergen (Make sure to save copies for yourself). I'm sure others that can think of more that I just can't think of right now, feel free to chime in.


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#5 Snookie

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Posted 07 January 2015 - 06:22 PM

FDA is so understaffed and having trouble auditing facilities here in the states that their focus has been on high risk products and companies.   I would think it would highly unlikely that they audit you unless you have a very high volume coming into the US, have had major problems. 


Edited by Snookie, 07 January 2015 - 08:27 PM.

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#6 fgjuadi

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Posted 07 January 2015 - 06:57 PM

FDA is so understaffed and having trouble auditing facilities here in the states that their focus has been on high risk products and companies.   I would think it would highly unlikely that they audit you unless you have a very high volume coming into the US, have had major problems think it highly unlikely that they audit your facility. 

Agreed.  We are low risk in the states and our FDA audit schedule is once every 5 years.   The audit is not charged, however there are a lot of charges if they find something wrong or have to stay or extend their audit.   I'm not sure about outside of the states, I'd imagine there are a lot of other customs laws you'd need to comply with. 


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#7 Aliaime

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Posted 08 January 2015 - 02:00 AM

Hello Aliaime,

If you have a login doesn't mean you have been registered. If you're registered you would be given a Food Facility Registration Number at https://www.access.fda.gov. There is also an option to search your company once you log in. You can ask for a confirmation copy to register your facility with the FDA as required by 21 CFR Part 1, Subpart H, and the public Health Security and Bioterrorism Preparedness and Response Act of 2002 by emailing fis@fda.gov or calling the FDA Industry Systems Help Desk via telephone 301-575-0156. AFAIK there needs to be an initial inspection. After that they are announced as a frequency of their discretion.

 

Thanks RG3.  Yes, we have the registration number which showed on the P/N.  Is this registration number equal to Food Facility Registration Number?  If yes, it seems that we have not been inspected by FDA before, so the inspection is not really necessary in this case? 


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#8 Snookie

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Posted 08 January 2015 - 05:01 PM

You can register and may never be inspected.  If you have a number you are most likely registered.  But you can login and search. 


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#9 YongYM

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Posted 09 January 2015 - 04:39 AM

Hello Aliaime:

 

I am from Malaysia and my company is producing biscuits (generally considered as low rick). But, we had been audited by the USFDA about two years ago [Our Health Authority told us that our country had been selected that year. The targeted industry was bakery producers]. According to the auditor (from Florida), USFDA will start to arrange more audit to those countries exporting their products to US. Last few years they came to Malaysia, later they will also go to other countries e.g. South Korea etc. So, just do your best for food safety & quality as well as to understand (and complied to) the new USFDA requirements, you should be alright.

 

 

Yong


Edited by YongYM, 09 January 2015 - 04:46 AM.

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