Jump to content

  • Quick Navigation
Photo
- - - - -

FDA Inspections/Investigations

SQF FSSC 22000 BRC IFS FDA

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

#1 Kellio

Kellio

    Grade - MIFSQN

  • IFSQN Member
  • 156 posts
  • 66 thanks
16
Good

  • Puerto Rico
    Puerto Rico

Posted 02 August 2019 - 03:11 PM

Good day Everyone,

 

I know this question is being ask already but I have been out of the site for a while. 

 

Could anybody share the latest experiences with FDA Inspections/Investigations?  Just curious to see what are the main objectives.

 

I work in a Spice and Extract Operation and we had FDA/ State of Texas Observation visit but we were alerted of the "SWABATON" coming.

 

Any experiences you can share will greatly appreciated.

 

Glad to be back

K



#2 Marshenko

Marshenko

    Grade - SIFSQN

  • IFSQN Senior
  • 265 posts
  • 100 thanks
39
Excellent

  • United States
    United States
  • Gender:Male

Posted 02 August 2019 - 03:14 PM

I had them in Tuesday and Wednesday actually.  No swabbing - they just wanted to observe processing/sanitation, look over FSPs, allergen management, training, and supplier approval documentation.



Thanked by 1 Member:

#3 bakeryscience

bakeryscience

    Grade - MIFSQN

  • IFSQN Member
  • 107 posts
  • 8 thanks
15
Good

  • United States
    United States
  • Gender:Female
  • Interests:Cooking and baking, photography, painting, pets, travel

Posted 02 August 2019 - 03:16 PM

They have never swabbed our facility before.



Thanked by 1 Member:

#4 The Food Scientist

The Food Scientist

    Grade - PIFSQN

  • IFSQN Principal
  • 602 posts
  • 150 thanks
105
Excellent

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

Posted 03 August 2019 - 07:36 PM

I was at a company still new and right before I got there they informed me they did get a FDA visit for swabbing. They told me they took around 20 samples from different areas in the facility (different zones) and swabbed for Salmonella & Listeria. They simply want to test your EMP. 

 

This may help you:

 

http://foodsafety.me...lity-swabathon/


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


Thanked by 1 Member:

#5 jkoratich712

jkoratich712

    Grade - MIFSQN

  • IFSQN Member
  • 58 posts
  • 7 thanks
5
Neutral

  • United States
    United States
  • Gender:Female
  • Interests:Food, books, bakeries, coffee, HACCP, sanitation

Posted 01 October 2019 - 08:44 PM

We have a site that the FDA is currently at. They are wrapping up day 2 and are planning on returning tomorrow. No swabbing, but did reference their website for us to get an idea of what to expect. It can be found here: https://www.fda.gov/...mental-sampling .

 

We are seeing them dig through about 1.5 years of records - reviewing every entry, etc. They informed us that 'this is nothing' and we can expect a full week next time. Much different then their visit 2 years ago, which was only 1.5 days and was more risk based on how they approached documents and records. 

 

Much tougher this time around.







0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users

EV SSL Certificate