Jump to content

  • Quick Navigation
Photo
- - - - -

What to expect during an FDA Audit?


  • You cannot start a new topic
  • Please log in to reply
4 replies to this topic

#1 FodfoodsafetyKate

FodfoodsafetyKate

    Grade - Active

  • IFSQN Active
  • 12 posts
  • 2 thanks
2
Neutral

  • United Kingdom
    United Kingdom
  • Gender:Female
  • Location:Forest of Dean

Posted 21 February 2020 - 08:22 AM

Hi everyone,

 

We have an FDA two day visit on Monday and Tuesday next week. We aren't too worried, however, be great to know if anyone else can shed some light on what exactly we can expect?

 

thanks



#2 Brendan Triplett

Brendan Triplett

    Grade - SIFSQN

  • IFSQN Senior
  • 280 posts
  • 86 thanks
46
Excellent

  • United States
    United States
  • Gender:Male
  • Interests:Rugby, Military, Reading

Posted 21 February 2020 - 10:52 AM

Hey,

 

Just had the FDA in here last week.  They are basically going to look up what your "riskiest" product is and follow it through your chain of manufacturing and distribution.  They will do a record review on day 2 and a walkthrough on day 1 and then will sit down on day 2 or 3 and give you some corrective action and advice.  They checked things like:

 

Pest control

allergen management

sanitation

building cleanliness

HACCP

CCP in depth review

 

Generally they are really good and they don't want to hurt you or the company.  You should be fine as long as you have the controls already in place.


Director of Operations/Vice President and SQF Practitioner in Pennsylvania
Brendan Triplett


Thanked by 1 Member:

#3 Charles.C

Charles.C

    Grade - FIFSQN

  • IFSQN Moderator
  • 17,393 posts
  • 4841 thanks
944
Excellent

  • Earth
    Earth
  • Gender:Male
  • Interests:SF
    TV
    Movies

Posted 21 February 2020 - 02:39 PM

Is the Process in UK for (?) the same as USA ??

 

Just curious. :smile:

 

@ Kate -  what do you actually make ?


Kind Regards,

 

Charles.C


#4 The Food Scientist

The Food Scientist

    Grade - PIFSQN

  • IFSQN Principal
  • 926 posts
  • 241 thanks
180
Excellent

  • United States
    United States
  • Gender:Female
  • Interests:Food Science, Nature, SQF, Learning, Trying out new foods, Sarcasm.

Posted 21 February 2020 - 02:47 PM

What Brendan said. They will look at your "riskiest" product and look thoroughly through that products documentation. They take Sanitation very seriously as well as Allergen Management. They will give out recommendations to you. Make sure your plant is clean and no Allergen cross-contact is present! Let everyone in your plant know you will be having an FDA audit. They will ask for Food Safety plan and ask you questions about it. Don't be terrified, they are not as scary as we think they are :)


Everything in food is science. The only subjective part is when you eat it. - Alton Brown.


#5 FodfoodsafetyKate

FodfoodsafetyKate

    Grade - Active

  • IFSQN Active
  • 12 posts
  • 2 thanks
2
Neutral

  • United Kingdom
    United Kingdom
  • Gender:Female
  • Location:Forest of Dean

Posted 24 February 2020 - 12:16 PM

Thanks everyone.

So far as you rightly said he has carried out the site tour. 

 

We actually produce smoked salmon......






0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users

EV SSL Certificate