25 replies to this topic

[Laura8]

Hi All


I have a few audits coming up, one of which is a US FDA audit.


Does anyone have any experience with the FDA and what I am likely to expect?



Any tips or advise will be much appreciated.



Many Thanks

[Rich G.]

Hi All


I have a few audits coming up, one of which is a US FDA audit.


Does anyone have any experience with the FDA and what I am likely to expect?



Any tips or advise will be much appreciated.



Many Thanks

It all depends on which industry you are in. I have found that the FDA audits are usually conducted by the State on behalf of the federal government and are usually pretty straight forward if they are routine and not in response to a consumer complaint or court order. They will probably spend a little time walking your facility and maybe reviewing interstate commerce shipping records.

[esquef]

Laura,

My experience with a FDA inspection was at a company the produced OTC drugs (menthol cough drops and antacids) as well as confections (mint tablets and hard candy). It was very involved, and the inspector had to see one product from each product catagory made from start to end, as Rich G. said - interstate commerce shipping records, label accuracy and accountability/reconcilliation (for OTC drugs) and a very detailed Good Laboratory Practice audit that focused on analytical teating. The last two were no doubt made more stringent because of the use of FDA controlled substances (menthol and calcium carbonate).

Good luck.
esquef

[Laura8]

We manufacture chocolate coated fruit & nuts aswell as fudge which is being exported to the US.

I have heard its like a BRC audit but perhaps more intense/ harder?

[mind over matter]

Hi All


I have a few audits coming up, one of which is a US FDA audit.


Does anyone have any experience with the FDA and what I am likely to expect?



Any tips or advise will be much appreciated.



Many Thanks

I recommend this....

http://www.fda.gov/I...uides/UCM074883

[Lynda Leopold]

Hello,
I am in the greenhouse produce industry in Canada. We had a visit from the FDA this spring. The basis for their inspection was the Code of Federal Regulation, specifically, 21 CFR sec 110: http://www.accessdat...cfm?CFRPart=110
It's really a general overview of GMP's. My experience was that they followed this format reasonably closely.
Regards,
Lynda

[Bill78]

Laura,
Our experience with the FDA is more in the lines of a standard GMP audit. Walking around, observing your process and focussing on cleanliness, hygeine practices, storage and potential cross contaminaiton issues. FDA inspectors ( or contracted State agencies) tend to "plant" their feet in one location and just watch and watch and watch. Two years ago the FDA inspector stood in the same location for 45 minutes. In the past they have not asked to look at any documention other than labeling but with recent FSMA, I have been hearing they are being more thorough with the paperwork. If you are GFSI certified, you should be fine. Best of Luck!

[JPO]

Laura,
Our experience with the FDA is more in the lines of a standard GMP audit. Walking around, observing your process and focussing on cleanliness, hygeine practices, storage and potential cross contaminaiton issues. FDA inspectors ( or contracted State agencies) tend to "plant" their feet in one location and just watch and watch and watch. Two years ago the FDA inspector stood in the same location for 45 minutes. In the past they have not asked to look at any documention other than labeling but with recent FSMA, I have been hearing they are being more thorough with the paperwork. If you are GFSI certified, you should be fine. Best of Luck!

We were recently FDA audited and the inspector did exactly as was noted in the above post. They watched several work stations, for about 1 hour at a crack. They also made the point to come in and observe sanitation after we had completed operations for the day.

Additionally, we DID do paperwork review, primarily training records as well as performing a mock recall-traceability exercise.

The inspector walked by a pallet of raw materials and essentially said "tell me when this came in, how much there was initially, how much you show now (and it had better match the physical stock on the floor), and where it went."

We counted the pallet of stuff, went to my office and checked out inventory on the computer and noted arrival date, shipper information, etc. then we found where the product was used, reconciled the amounts to come up with all the product, and off we went.

It's a bunch like a GFSI compliant inspection, with significantly more emphasis spent observing employees and employee practices.

Pray nobody decides today is the day to itch their nose, then not wash hands and change gloves.

[Jeff Ort]

If you document everything and have a good GMP program you should be fine. The inspectors really want to see that there are controls in place and corrective actions available should reason arise. I have had 2 audits in two years and being certified SQF 2000, it made life very easy for this. They did ask if we conduct mock recalls and did want to know about processes. Sanitation is their biggest concern it seems. So if it is not a surprise, check the corners and ceilings. Good Luck

[cesspadilla]

We were recently FDA audited and the inspector did exactly as was noted in the above post. They watched several work stations, for about 1 hour at a crack. They also made the point to come in and observe sanitation after we had completed operations for the day.

Additionally, we DID do paperwork review, primarily training records as well as performing a mock recall-traceability exercise.

The inspector walked by a pallet of raw materials and essentially said "tell me when this came in, how much there was initially, how much you show now (and it had better match the physical stock on the floor), and where it went."

We counted the pallet of stuff, went to my office and checked out inventory on the computer and noted arrival date, shipper information, etc. then we found where the product was used, reconciled the amounts to come up with all the product, and off we went.

It's a bunch like a GFSI compliant inspection, with significantly more emphasis spent observing employees and employee practices.

Pray nobody decides today is the day to itch their nose, then not wash hands and change gloves.

I think just following the proper sanitation and procedure it will be fine. Although, I do hope that nobody will do something... :)

[RMAV]

Hi All


I have a few audits coming up, one of which is a US FDA audit.


Does anyone have any experience with the FDA and what I am likely to expect?



Any tips or advise will be much appreciated.



Many Thanks

I assume your audit has taken place. What was your experience?

[fgjuadi]

Bumping a dead thread but Guess Who showed up for an audit yesterday and are returning to complete this week. 

 

I'm very interested in FDA audit techniques / documentation. 

 

On one hand I'm super confident our employees are doing the right thing and trained to respect food safety, and I'm really glad there is a regulatory agency who checks the food I eat.  On the other hand I'm neverous because I see things they don't...and it's the FDA, it's nerve wracking. and we're just growing and learning, not a mature corporation.  It's like having to talk to a cop even though you're just walking down the street doing nothing.  Hooray, I get a chance to show off my documentation and I get an outside viewpoint that will give me GREAT advice for improvement in our programs, but the stakes just jumped from "not having a certain 3rd party cert for a month" to "IT'S THE FDA"

 

Here's my horoscope for tomorrow - "Study of intellectual or spiritual subjects that particularly interest you could keep you at home for much of the day, Cancer. More than one visitor might drop by in order to discuss these matters, perhaps bringing a few books. Discussions could take on an imaginative, idealistic, and even mystical level, which could prove inspiring for all involved. Take notes, because you'll want to be sure and remember these conversations."

 

Wish me luck?

[Setanta]

GOOD LUCK! 

[Marshenko]

Good luck! :)

 

From my limited experience dealing with folks from the FDA (during/after a large recall), they were mostly dolts, but maybe you'll get lucky and get the one ma'am or sir who has read a book...

[Mr. Incognito]

We manufacture chocolate coated fruit & nuts aswell as fudge which is being exported to the US.

I have heard its like a BRC audit but perhaps more intense/ harder?

 

I'm sorry I saw "Fudge which is being exported to the US." and my mind started wandering to things like "Why isn't peanut butter fudge being delivered to me for an external quality test."  I love peanut butter fudge.

 

Slightly more seriously... I haven't had the pleasure to be a part of an FDA inspection but our NY Agriculture and Markets rep typically gets contracted to do it for whatever reason.  I was told the same thing as other posters that it's pretty much a GMP inspection and making sure your doing what your supposed to do.  I wouldn't expect it to be as thorough as a GFSI audit but I'm not sure.

[Pizza&Sandwich]

Bumping a dead thread but Guess Who showed up for an audit yesterday and are returning to complete this week. 

 

I'm very interested in FDA audit techniques / documentation. 

 

On one hand I'm super confident our employees are doing the right thing and trained to respect food safety, and I'm really glad there is a regulatory agency who checks the food I eat.  On the other hand I'm neverous because I see things they don't...and it's the FDA, it's nerve wracking. and we're just growing and learning, not a mature corporation.  It's like having to talk to a cop even though you're just walking down the street doing nothing.  Hooray, I get a chance to show off my documentation and I get an outside viewpoint that will give me GREAT advice for improvement in our programs, but the stakes just jumped from "not having a certain 3rd party cert for a month" to "IT'S THE FDA"

 

Here's my horoscope for tomorrow - "Study of intellectual or spiritual subjects that particularly interest you could keep you at home for much of the day, Cancer. More than one visitor might drop by in order to discuss these matters, perhaps bringing a few books. Discussions could take on an imaginative, idealistic, and even mystical level, which could prove inspiring for all involved. Take notes, because you'll want to be sure and remember these conversations."

 

Wish me luck?

We just had a surprise visit a couple weeks ago from a state inspector that also contracts the FDA audits. She was very knowledgeable, had experience in industry prior to government work. They looked at almost everything our SQF auditor did. Shipping & receiving records, production records, mock recall records, FDA registration, thermometer & scale calibrations, Products register, ingredient list, plant tour for GMP's & sanitation, sanitizer check, labels, HACCP plans, pest control, environmental testing, etc.

It wasn't as intense as the SQF audit (ie: she didn't dig deep into records). When she asked for something, I provided documentation or explained it.

Be confident in your knowledge and your program. You know it best.

[Snookie]

Having been part of many FDA audits, they vary as any audit does by who is doing the audit.  I have had really intense 7 day audits ( it was a small plant), and 30 minute "keep up the good work" audits.    Good luck!

[Slab]

As others have previously stated it really depends on the auditor and the nature of the call (general surveillance vs. response to report).

 

In my experience with the FDA the auditor will generally start like any other audit;

 

• Introductions (identifying key personnel for interviews and structure of audit)
• Desk audit and interviews
• GMP, SSOP, procedures and practices on the floor
• CAR and closing notes (you will receive a 483 so follow up and address investigator's observations before exit.  Make corrections as needed during audit for a good show of due diligence)

The FDA is a mandatory regulatory body for legal commerce unlike GFSI.  They have the authority of cease and seizure. Do not take them lightly. However, unless it's gross negligence they are extremely forgiving of the missing "ticks and tocks".

 

The audit may take one to three days depending on the size of your facility.

 

Hooray, I get a chance to show off my documentation and I get an outside viewpoint that will give me GREAT advice for improvement

 

 

An audit is the last place you want to be for "great advice".  An audit is not training day.  Go into it with confidence. 

 

Here is a link to various FDA audit guidlines;

 

http://www.fda.gov/I.../ucm2005386.htm

[Shyguy77]

First off - I wish you good luck on your audit.



As stated by Merle and Slab; FDA audits can be anything from 1 day to a 3-4 day experience. I've had the pleasure of dealing with both of the types mentioned in their post. And Heaven help you if the audit doesnt go your way, it can be a 2-3 week circus.


IMEX a typical FDA audit is like an extended GFSI audit. They spend a 1-2 days going through you procedure an records and 1-2 days walking about the facility, warehouse and grounds depending on the size of your operation.

Edited by jpredmore, 26 March 2014 - 07:09 PM.

[fgjuadi]

Thanks all!  Only time will tell, but you definitely put my mind at ease and made the waiting game a little less stressful.

 

 

• CAR and closing notes (you will receive a 483 so follow up and address investigator's observations before exit.  Make corrections as needed during audit for a good show of due diligence)

Um, holy flipballs, no way in hell am I walking out with a 483.  I would be so embarrassed I would die.  My factory isn't disgusting and there are no food safety issues like dirty air guns or poor GMPs.

 

 

Here is a link to various FDA audit guidlines;

 

http://www.fda.gov/I.../ucm2005386.htm

 An audit is not training day.  Go into it with confidence. 

 

I KNOW!  Our *first* audit, and it's not some consultant or 3rd party training audit, it's the FDA. The mfin' F. D. A.

 

 

It is a routine audit, and we don't do anything high risk.  We'll do okay.  If anything, they will find problems we already have actions plans for.  We go down for passover, so we have that time allotted for paint, walls, etc.  We had a similar audit in 2010 and passed with no 483.

 

Whew.  Thanks.

 

Okay, here's an awkward question  -

 

I've been through two FDA audits before, but not as the sole person responsible. Once on the sidelines as a sister factory was audited (The QA Manager was AMAZING!  If I'm ever in a position to hire someone who should make 6 figures, it was that woman).  That one went swimmingly. 

 

The other was at my previous position, a pre-labor-law style hell factory where people suffered amputation and concussion everyone was miserable and on rotating monthly shifts (day shift 1 month, swing the next, grave the next, ugh).  The place was filthy, and I was already making plans to skedaddle when we were hit by the FDA last October.  The QA dept was roughly 20 people, so I had very little to do with it - maybe 2 hours out of the audit (they reviewed pest control, I have my QAC and am awesome, so no issues).

 

I'm working in the same area...I can;t remember the FDA auditors names from October...but...I think one of them might be the same auditor? She looks os familiar! I want to ask but I'd feel like a jackass if it was the same woman and I'd totally forgotten her.  On the other hand, I in no way want to be associated with the dirty, nasty factory she had to audit and found Salmonella in (that's why I dropped that crap job even before landing another QA job - and let's be honest, we're a valuable bunch).

 

I know the company got a 483 (again, mortifying, though I would have shut um down and salted the earth) and hte name of the company...can I look it up on the FDA website to see if it was the same audit team? O do I have to request via FOIA?  Cuz that would take way too long and be way too much work. Can I just ask her?

Edited by magenta_majors, 27 March 2014 - 02:05 AM.

[Slab]

We had a similar audit in 2010 and passed with no 483.

 

 

Or maybe I should have said "you may receive a 483".  

 

Thirteen years in seafood and every audit followed with a 483.  Granted 99% were minor.  Perhaps our investigator was just a tough one?

 

483 issuance is fairly common after an audit, however they usually cover minor observations. When a 483 is issued with a warning letter, then you have a problem.

 

 

The other was at my previous position, a pre-labor-law style hell factory where people suffered amputation and concussion everyone was miserable and on rotating monthly shifts (day shift 1 month, swing the next, grave the next, ugh).  The place was filthy, and I was already making plans to skedaddle when we were hit by the FDA last October.

 

 

That place does sound awful.

[fgjuadi]

Or maybe I should have said "you may receive a 483".  

 

Thirteen years in seafood and every audit followed with a 483.  Granted 99% were minor.  Perhaps our investigator was just a tough one?

 

483 issuance is fairly common after an audit, however they usually cover minor observations. When a 483 is issued with a warning letter, then you have a problem.

 

 

 

That place does sound awful.

Ah, seafood is extra risky - I didn't mean to imply your factory was dirty or had salmonella, that's probably a huge risk for you.  Our product is chocolate, so pretty low risk and the factory is tiny, so we'd have to be doing something outrageous.  If I was the FDA I'd be tougher on seafood. But it is good to know a 483 is common - I thought they only issued them when factories were as bad as my last one. 

 

Yes, the amputation that happened while was I working there was the third amputation resulting from the same equipment/process in two years, which they hadn't bothered to fix/modify.  The concussion was actually a forklift injury they were not compelled to report because the worker injured was a temp.  I had called OSHA to come do a "help" audit, but they couldn't because we had so many violations and open investigations.  At one point the plant manager asked if I "Really wanted to work in a place that was OSHA compliant".  Um?  Yeah, I do.    I discovered they were fogging generic-brand Vapona and then running organic product first because it didn't require a clean out.  Without cleaning FCS.  Starting right up on organic and questioning the lab when your sample si positive for Dichlorvos.  Plus, they paid their employees flip all - minimum wage to clean up blood and wear respirators on a rotating shift where you might die.  My Plant Manager would flat out lie and act abusive towards the FDA, 3rd party,  and customer audits. He would openly mock and ridicule employees and delighted in firing them.  Skilled workers and leads would work 20-30 days without days off.  Another supervisor got peed because I told a devout Jewish convert she did NOT have to work on Saturdays and had her bring a note from her rabbi.   I couldn't morally keep working there any longer, and I broke a contract to stop.    It was scary to not have income when there is  rent to pay, but I'm really glad I took time and found the prefect most amazing job ever.    Now before I take a job or approve a supplier, I look at OSHA and FDA records.

 

This audit will be much smoother, I am hoping. 

Edited by magenta_majors, 27 March 2014 - 11:19 AM.

[fgjuadi]

Update - Whew!

 

What a relief!  My first audit at the new plant and it went okay.  No 483 - 3 discussion points will be noted on the letter, one is as simple as assigning frequency of daily to something we already do daily, the other two we were aware of (damn you, 18 in perimeter line) and are working on solutions (down from 10 in 2010, all 10 of those issues had been corrected).  Under FSMA they will do at least one precautionary audit per 5 years and it was our turn.

 

They noted many smaller issues we corrected immediately.  Despite my corporates advice, I willing gave them copies of our documentation when requested.  I understand that legally we were not obligated to give out copies, but it makes everything much smoother, and they didn't ask for CAPA records or anything that was a record of a food safety problem. Plus, it makes writing a report a billion times easier for them, and I want an accurate & complete report. What am I gonna say, "I prefer you go buy a bar in a market instead of taking a label now".

 

There were two pleasant auditors, and a couple times I was left alone with them and they would split up, and they were in the factory when no supervision was on the first day as we were at training / on vacation /sick (only our mechanic & sales on site!Not even an admin!)

 

My sister QA Manager was helpful and empathetic this time.  I'm really starting to like her actually.  My team was brilliant!  They corrected immediately without hesitation or protest and answered everything HONESTLY, which was something I stressed.

 

They observed cleaning practices, a production run, and a tour of the facility from start to finish.  They reviewed - SSOPs to see if they were being followed, Pest Control, cleaning records, labels, EMP records, raw material testing/vendor approval, mock recall, and Customer complaints.  They were pleased that we trended and communicated positive feedback to the team and satisfied with a foreign object complaint investigation.

 

The product they observed was a first time production of a new bar, which ended up delicious.  It was the perfect bottle to smash on our product launch boat as she left the dock.

 

-Majors

 

 

 

[Slab]

Congratulations!  It sounds as if you have an outstanding team you're working with.  

[Aliaime]

Hi guys,

 

How do you all get the FDA audit?  Is there any application for this or is FDA just decided which facility to audit?

My company, which is a foreign food ingredient / dietary supplement manufacturer, would like to do such audit as we have found other manufacturers mentioned on their website that they have registered with the U.S. FDA and successfully inspected by the FDA for the manufacture of dietary supplements in accordance with 21CFR111.

 

We have registered our facility but I have no clues how to apply for the FDA inspection.

Can someone give me some clues on this?  Thank you so much.