Environmental Swabs During FDA Inspection, what to expect?

Hello!

We just had the first half of our annual FDA audit today. They are coming back tomorrow to take about 50 swab samples for Salmonella. What advice does everyone have? We've never had anyone take swabs of our facility before.

(Ironically, I answered someone's post a few weeks ago saying the FDA has never taken environmental swabs here!)

Thank you!

Hello!

 

We just had the first half of our annual FDA audit today. They are coming back tomorrow to take about 50 swab samples for Salmonella. What advice does everyone have? We've never had anyone take swabs of our facility before.

 

(Ironically, I answered someone's post a few weeks ago saying the FDA has never taken environmental swabs here!)

 

Thank you!

Did they ask for your sam results based on your testing?

What was the reason they gave for coming back to do swabbing - did you ask?

One of our clients had a recent FDA FSMA inspection and the PCQI said they did swab sampling as well.

It wasn't related to any findings. They let us know they would be coming back to take samples as soon as we sat today. Seems like it is going to become standard, or at least more common.

These are just a few of the things we did when the FDA came to our facility ( but we make cheese =] ). 

• Print a map of the facility for yourself and the inspector. Go with them when they swab. Mark down on your map the corresponding sample number and write down the specific area in a notebook.
• Take a camera and photograph each swab site. 
• Clean and sanitize Zone 1's right after they swab (broth from the swab gets on surface, etc). 
• Write down the lot/batch and type or product that will be run that day. Hold until results are back, if possible. 

 

These are just a few of the things we did when the FDA came to our facility ( but we make cheese =] ). 

 

• Print a map of the facility for yourself and the inspector. Go with them when they swab. Mark down on your map the corresponding sample number and write down the specific area in a notebook.
• Take a camera and photograph each swab site. 
• Clean and sanitize Zone 1's right after they swab (broth from the swab gets on surface, etc). 
• Write down the lot/batch and type or product that will be run that day. Hold until results are back, if possible. 

 

This is good advice. What's also helpful is that they gave you a heads up that they would be swabbing. I don't think there is value in duplicating their swabs -- it increases the likelihood of presumptive positives, errors, etc. and if they get a positive and you get a negative, your negative will mean nothing to them.

If your production schedule normally has a clean at the end of each day, I would be hyper-focused on ensuring SSOPs are followed exactly and that you carefully inspect for niche areas. Have a plan to bracket and keep on HOLD the production that would be affected by the swabbing activities until you get results back as CRLamb mentioned. Even if you test finished product for Salmonella, if you get hits on Z1 surfaces you wont be able to convince them that you don't have conditions whereby product may become adulterated. They can also hit you with the 'conditions wherby' with having a lot of environmental positives in Z2-3 if they see enough GMP issues.

Once they've finished swabbing and inspection activities, if scheduling permits, to ensure a clean break, I would clean and sanitize the line and conduct environmental swabbing that would cover the same sites. 

Best of luck.

Hello!

 

We just had the first half of our annual FDA audit today. They are coming back tomorrow to take about 50 swab samples for Salmonella. What advice does everyone have? We've never had anyone take swabs of our facility before.

 

(Ironically, I answered someone's post a few weeks ago saying the FDA has never taken environmental swabs here!)

 

Thank you!

Do you already take swab samples yourself ? If so, including  Zone 1/Salmonella ? (various articles recommend avoiding Zone 1, for "debatable" reasons)

Excellent advice.

My only added advice is cease production and conduct sanitation in all areas they swab after they swab.  Then, conduct your own swabbing of the areas they swabbed after the sanitation.  Hold your production of product until your swab results come back (if possible).

This way you are assured if any of their swabs come back positive you have limited product to hold / recall and you can show you cleaned / removed the salmonella with your follow-up testing and results (hopefully all negative).

If you do this I would be candid with the FDA inspector about your intentions.  This way no one is caught by surprise.

 

These are just a few of the things we did when the FDA came to our facility ( but we make cheese =] ). 

 

• Print a map of the facility for yourself and the inspector. Go with them when they swab. Mark down on your map the corresponding sample number and write down the specific area in a notebook.
• Take a camera and photograph each swab site. 
• Clean and sanitize Zone 1's right after they swab (broth from the swab gets on surface, etc). 
• Write down the lot/batch and type or product that will be run that day. Hold until results are back, if possible. 

 

This reminds me of a story from a former quality manager at a plant I inherited from him.  The FDA came in and took over a 100 swab samples for listeria.  This plant had very poor sanitation and very unskilled workforce.  

As soon as the quality manager found out the FDA was going to sample he excused himself from the inspectors and left the production manager with them in the meeting.  He then walked around the facility with a spraycan of lysol spraying all zone 2 and 3 surfaces.  He told me he went through a dozen cans of lysol.  The zone 1 areas he made concentrated sanitizer solution and foamed / flooded zone 1 surfaces.  Then purged the product.

I was shaking my head when he told me this...BUT, all the FDA swabs passed, all negative for Listeria.

This same person told me when I asked him about swabbing drains, "Why would you want to swab drains?  You know there is listeria there."  :shaking my head:

Thank you everyone for the advice, it helped a lot. They just finished up taking samples; luckily there were not really any surprises. Everything they tested was in zones 2 and 3. Mostly floor, table legs, exterior of equipment, cart wheels, buttons/on switches, etc. I would say about 80% of the samples were taken in the packaging area, which we expected.

It was definitely a great learning experience and will help us improve. 

This reminds me of a story from a former quality manager at a plant I inherited from him.  The FDA came in and took over a 100 swab samples for listeria.  This plant had very poor sanitation and very unskilled workforce.  

 

As soon as the quality manager found out the FDA was going to sample he excused himself from the inspectors and left the production manager with them in the meeting.  He then walked around the facility with a spraycan of lysol spraying all zone 2 and 3 surfaces.  He told me he went through a dozen cans of lysol.  The zone 1 areas he made concentrated sanitizer solution and foamed / flooded zone 1 surfaces.  Then purged the product.

 

I was shaking my head when he told me this...BUT, all the FDA swabs passed, all negative for Listeria.

 

This same person told me when I asked him about swabbing drains, "Why would you want to swab drains?  You know there is listeria there."  :shaking my head:

Oh my....this really seems like something he should have kept to himself...forever.

No kidding! I keep thinking about it and I cringe every time!

Thank you everyone for the advice, it helped a lot. They just finished up taking samples; luckily there were not really any surprises. Everything they tested was in zones 2 and 3. Mostly floor, table legs, exterior of equipment, cart wheels, buttons/on switches, etc. I would say about 80% of the samples were taken in the packaging area, which we expected.

 

It was definitely a great learning experience and will help us improve. 

Presumably you now await the actual results. With bated breath ?

Since zone 1 was avoided, seems the FDA are currently trying to avoid headaches. Very strange.

PS - JFI, in the case that a thermal bactericidal step exists, IIRC, FSIS recommend to place lower priority on items like drains in pre-thermal stages.

We just got the results back. Everything came back negative!