Hello All,

I have two questions:

1. I am in a small device manufacturer (<10 employees including the owner/president). As such, the management is traveling a significant part of the time and the office is left in the care of the operations manager who is not skilled in dealing with the FDA. We are expecting the FDA to visit our facility sometime in the next 6-8 weeks (for cause) and are wondering if it is appropriate for office manager to politely request that the investigator return when the managemrent is available (1-2 days depending on travel)?

2. Does anyone have a brief presentation, appropriate for a small office, on "What to do when the FDA comes a knockin" ?

Thanks to all in advance.

I suggest training your operations manager to deal with the FDA ASAP.
Or get a new one. If he/she is not capable of dealing with the FDA in a regulated environment then he/she is not the right person to be operations manager.

If they are visiting for cause I'm sure they won't take kindly to being asked to return. Of course you don't have to let them in right then and there but they can get a court order if so inclined and you really don't want them to do that.

Something to consider: If replacing or training the ops manager is out of the question you might also be able to hire a local consultant to be on-call with a deal to get to the office within 1/2 hour of an emergency call - the inspector can be stalled that long.

I used to have a documented procedure to dealing with the FDA but that was a few jobs ago. It essentially told the receptionist to
1) Request credentials
2) Ask the inspector to have a seat in the waiting area
3) call me
4) if I'm not available, call the president
5) if we're both not available, call the plant manager
etc etc.

Here's the deal in a nutshell....if you deny entry he'll come back, but probably with Matt Dillon and Wyatt Earp in tow.

Does the work stop when the boss isn't there? Probably not and neither do your regulatory/legal requirements.

It is very unlikely the FDA will arrive unannounced. Your companies "official correspondent" will receive advanced notice, that is unless the company has been in the national headlines. Your "6-8 weeks" statement leads me to believe the FDA has sent notice? If the notice has been sent, suggest some dates when the right people are in the office.

Our office is a block from one of FDA's most active District offices, unannounced inspections are rare.

I would suggest professional help if the expertise is not on staff. The FDA has destroyed more than a few small companies.

Google (http://www.google.com/search?client=firefox-a&rls=org.mozilla%3Aen-US%3Aofficial&channel=s&hl=en&q=FDA+inspection+preparation&btnG=Google+Search)

The FDA has destroyed more than a few small companies.

Google (http://www.google.com/search?client=firefox-a&rls=org.mozilla%3Aen-US%3Aofficial&channel=s&hl=en&q=FDA+inspection+preparation&btnG=Google+Search)


So has stupidity when someone demands they get a warrant to gain entry.

It is very unlikely the FDA will arrive unannounced. Your companies "official correspondent" will receive advanced notice, that is unless the company has been in the national headlines. Your "6-8 weeks" statement leads me to believe the FDA has sent notice? If the notice has been sent, suggest some dates when the right people are in the office.

Our office is a block from one of FDA's most active District offices, unannounced inspections are rare.

I would suggest professional help if the expertise is not on staff. The FDA has destroyed more than a few small companies.

Google (http://www.google.com/search?client=firefox-a&rls=org.mozilla%3Aen-US%3Aofficial&channel=s&hl=en&q=FDA+inspection+preparation&btnG=Google+Search)

Is that how it is now?
When I was in a regulated business (device and drug) all of our visits were surprise. But it's been 5 years since I was there.

Dear B Krause,
Before you read below. One question - Does your product cross state lines?
If yes, continue below. If not, you are out of the FDA's charter.

The current audit approach for the FDA on inspections of medical device companies is a 5 day notice. However, they may negoatiate with you for a shorter time. It has happened where I was called on a Thursday and they asked if they could come in on Monday.

A buzzword for you is the "most responsible party". This is the person that will be required to sign the 482. One FDA person shared with me that the "come back later, when when the managemrent is available" is an old method of delaying the audit. I am sure your intentions are pure in this request. Unfortunately, this is not a good approach. Please note Randy's statment: "Does the work stop when the boss isn't there? Probably not and neither do your regulatory/legal requirements."

What you want to do or have someone do is go to: http://www.fda.gov/ora/inspect_ref/iom/
This is how the inspector is to conduct the inspection.

review chapters 5 and 4 for normal inpections.
If your cause involves injury and/or recalls chapter 7 and 8.

Chapter 2 tells that they have the authority to come and visit.

If you do not have a copy of 21 CFR 820 go to:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
type in 820.180 look at subsection c. These are the areas that the FDA currently does not have right inspect due to 5th admendement rights.

I do not have a presentation for FDA preparation. Some points I would stress.
1. Be open, honest, and direct in your answers. Scant or cautious answers could trigger concerns.

2. Do not be defensive. The FDA inspector is trained to focus on the processes not the persons.
Do you remember for this product you are the product expert. Be proud of your expertise.

3. Demostrate your documented process, example, discipline, effectiveness. Best way to answer is to show the documented process, and show a good example.
If you have a way to demonstrate discipline, even better.
When ever possible, show the effectiveness of the processes. For example: Utilization KPI shows the effectiveness of good maintenance.

4. Stick to the facts. Do not fib.
If you do not know the answer it is better to say so than to say something that could be proven wrong.

5. Be black and white in the answers. Avoid using words like: most times, usually, sometimes, depends, maybe, etc as they are usually used by persons that do not follow the processes

6. Do not share your personal feelings about the processes
It is a given that every single one of them can be improved upon.

7. Do not volunteer problems, let the auditor find them.

Do you best not to be considered difficult. As you read the IOM above, you will discover that the FDA has a database and post comments about the audit experience by company.

Unless you are doing something extremely unsafe for patients or staff. The FDA will allow you to make corrections to your system. However, if you system does require legal action, you will be dealing with the Department of Justice.

The people who lock your doors if it comes to that will be U.S. Marshals.

However, this only happens in extreme cases. Since, you have some concerns go to http://www.fda.gov/foi/warning.htm and the warning letters.

Warning letters are a part of the esculation process.

The thing that troubles me is, if they are coming for cause, why is the people considered excutive managment traveling? Has the situation been corrected? Have you followed your documented CAPA process that meets 21 CFR 820.100 regulations. You may also visit 21 CFR 820.198 concerning Complaint Files.

One of those things that you should never tire of hearing and I am more than will to tell you is: You whould be following your processes everyday to produce the a safe and effective medical device.

Massively :2cents:

Patatha,
Very good response.

Phil

Hello All,

I have two questions:

1. I am in a small device manufacturer (<10 employees including the owner/president). As such, the management is traveling a significant part of the time and the office is left in the care of the operations manager who is not skilled in dealing with the FDA. We are expecting the FDA to visit our facility sometime in the next 6-8 weeks (for cause) and are wondering if it is appropriate for office manager to politely request that the investigator return when the managemrent is available (1-2 days depending on travel)?

2. Does anyone have a brief presentation, appropriate for a small office, on "What to do when the FDA comes a knockin" ?

Thanks to all in advance.

Does your organization have a management representative appointed as required by 820.20? If so is that person traveling also?

It's hard to fathom that the operations manager and office manager would not have enough working knowledge of your QMS between them to be able to handle an FDA audit.

Thanks for the valuable info, Pataha

I, personally, have never been involved with an organization which has received warnings or notices preliminary to an on-site inspection by either the FDA or FAA. Therefore, ALL our on-site visits by regulatory folk were on an appointment basis. It is my understanding government regulators may make surprise visits, but I have never heard of one being made until AFTER a lot of shilly shallying for weeks and months prior. THOSE visits do come with marshals and padlocks; sometimes even with drawn weapons. When they do come in like that, they will also be videotaping EVERYTHING to document their actions were 'by the book.'

I can tell you flatly that trying to deny entry creates many more problems for the target organization than simply escorting an inspector through the premises and answering questions in simple monosyllables like, "Yes." "No." "I don't know."

One of the super giant drug companies has a large operation near my home and many of the quality employees are members of one of my ASQ Sections. They recently completed a waltz with the FDA, during which the FDA shuttered one of their manufacturing lines for a year. The upshot was nothing was actually WRONG with the manufacturing system, BUT the company had been sloppy in training and requiring personnel to DOCUMENT their activities. The lack of "Profound Knowledge" about the necessity for such documentation resulted in many folks being laid off without pay and the company paying millions of dollars to consultants to come in, set up document systems, and train the company personnel in the "why" and "how" of maintaining those records.

Bottom line:
I can't think of anything more important than having the responsible management executives on-site to receive and escort the FDA representative, especially after receiving the "for cause" notice. I recall one of my friends describing a government regulator's response when told the company executive was "unavailable."

"The only excuse I'll accept is if he's dead or in jail! Get him out here, now!"

Take a look at my old post (http://elsmar.com/Forums/showpost.php?p=83140&postcount=2). Also look at this article in MD&DI (http://www.devicelink.com/mddi/archive/07/08/017.html). There is a procedure that you can use as a model in How to Pass FDA Factory Inspections (http://www.touchbriefings.com/pdf/954/MDC_techEDITED.qxp.pdf). Good Luck!

Our experience differs on one point:

> 7. Do not volunteer problems, let the auditor find them.

Our understanding, so far seemingly borne out by experience, is that when a potential FDA correction/recall situation is on the horizon, it's a very good idea to be pro-actively in contact and informative to your District's Recall Coordinator. It's a given that they'll be objective, but still it can't hurt to have them know your side of the story first and how to reach you by phone.

In our case, an OEM customer has been demanding a Recall (probably Class III) of a large amount of inventory of a low-risk Class II family of products that we made partly to their specs, in a complex situation where it's not completely clear who has primary regulatory responsibility. The core problem, totally our fault, is that one of our sterile barrier packaging processes was instituted long enough ago that its stability records didn't meet the customer's current audit expectations. We don't think even a Correction is justified because there have been zero reports of either patient harm or sterility loss over a large (>1 million units) statistical usage base. The key process has been reviewed satisfactorily by six FDA/ISO audits over the past five years, was recently approved by a process validation regulatory consultant and has been retrospectively re-validated. So far the FDA hasn't chosen to take the side of the customer, which is fine by us.

Certainly we would agree with the original point, though, that once an auditor is on premises you should wait for his or her questions and limit your responses to exactly what was asked.

Take a look at my old post (http://elsmar.com/Forums/showpost.php?p=83140&postcount=2).

See 21cfr.180c, for records you are not required to give them.


Just to clarify, I believe Al is referring to 21CFR §211.180(c).

Just to clarify, I believe Al is referring to 21CFR §211.180(c).
4 years and nobody noticed that. Actually it's 21cfr820.180(c).

Hello Pataha,

Thanks for the information and overview of conduct during an inspection. I probably should have been a little more up-front in saying that the company was issued a warning letter, which was responded to, about 1 year ago. I am expecting the FDA to show up unannounced (for cause) any day to follow up on the warning letter.

We are a small operation (less that 10 people) and utilize a number of consultants to fill in the gaps, including regulatory. Beacuse of this structure, the president is traveling extensively and the "most responsible" individual available in most cases is the operations manager. Hence, my concern.

We did respond to the warning letter and have made improvements through our CAPA system. I strongly believe that we can defend our improvements and systems - I was just checking to see if "can you come back tomorrow when the president and regulatory manager can be available to adequately address the inspection?" is an acceptable response to the knock on the door.

Thanks Again

Were the deficiencies in your Warning Letter serious? Our last warning letter was in 2003, for three minors. They were satisfied with our responses, and haven't made a follow-up since then.

If you're pretty sure they're coming in soon anyway, and you're ready other than for personnel schedules, why not initiate a dialogue with them in which you explain the small-company issue and ask about scheduling an inspection when the Most Responsible Person and the regulatory consultant can be there?

Hi B Krause,

Thank you for the clarification.
I think by now enough poeple have pointed out that asking to come back after they arrive will not fly.

In my last company, wewere blessed with the Section Chief and an inspector. It turns out that Section Chiefs have a kpi of observing an audit.

One of the owners that very question before they signed the 482. The response was very close to an earlier post about if the business does not stop when he owners are away, then it falls upon the most responsible person be in the audit.

Since, you are a small business, you may want to call the FDA's small business group for their take on it - yous is Marie Falcone at 215.717.3703. the guide for FDA's small business is http://www.fda.gov/ora/fed_state/Small_Business/sb_guide/default.htm
You can verify the 5 day notification be inspection and the current timeline between inspection. In the area I moved out of we were on a 24 month cycle. Their office was only 30 minutes away.

I concur with MIREGMGR, that if you are a feeling that they are coming, stara dialogue with them, it should give you some piece of mind after talking with them.

If the operations manager is the most likely to be the one in the inspection, have him review chapters 5 then 4 in the IOM at http://www.fda.gov/ora/inspect_ref/iom/ChapterText/5_2.html . The IOM is updated every March and is always an interesting read. It is the way the FDA is expected to perform an audit. It does not hurt if you can speak in the same terms as the FDA.

As to your stress, MIREGMGR pointed out that the FDA has not returned to his site 5 years. The FDA has a very large charter and not a whole lot of staff to pull it off. They may not come within the time frame that you feel. Of course they may.....

As to your stress, MIREGMGR pointed out that the FDA has not returned to his site 5 years. The FDA has a very large charter and not a whole lot of staff to pull it off. They may not come within the time frame that you feel. Of course they may.....

FDA also considers public risk. If the device isn't invasive or widely distributed, B Krause's company may not be very high on their 'To Do' list.

4 years and nobody noticed that. Actually it's 21cfr820.180(c).

I guess I didn't read it back then. And whoops - forgot we were talking about devices. :o

I was at a company a few years ago which had an unannounced for cause inspection by the FDA.

At the time the company was in the processes of closing the facility and relocating to another state. When the FDA showed up, all senior management was out of the building/state.

We immediatly called the responsible senior management and got them on a plane to come back.

We were 100% up front with the investigator and explained the situation. We asked politely if she could return the next day, she declined and indicated she would like to start her research that first day. We complied with her request and provided all the basic information, facility tour, and answered the questions we knew.

She did arrive back in our facility the next day (senior management arrived) and they completed any unanswered questions.

Luckily the inspection was short and sweet without any 483's issued.

We were fortunate that people who were in the facility the first day were very familiar with the situation and could answer most of the questions.

I was at a company a few years ago which had an unannounced for cause inspection by the FDA.

<SNIP>
Luckily the inspection was short and sweet without any 483's issued.

We were fortunate that people who were in the facility the first day were very familiar with the situation and could answer most of the questions.'nuff said? Considering the potential consequences, it makes sense to have someone with authority and responsibility "on call" to come in and answer questions for an inspector, especially when there is a pending action. Just how long an inspector is willing to sit and cool his/her heels waiting is always going to be a crap shoot.

Maybe, just maybe, an alternate solution might be to have a on-site escort and a telephone conference with the off-site authority to mollify the inspector expecting authoritative answers to questions.

Working for the FDA for over 20 years, FDA does not take kindly to inspection refusals or sample collection refusals (both either partial or total refusals). If the firm is in operation, then FDA can come knocking, no matter if top management is there or not. This is not an excuse for a refusal- because the fimm is in operation! If FDA is refused (or is kept waiting for a while)(especially as a result of performing a compliance or for cause level III audit inspection or sample collection), problems will occur! Why would a firm want to have FDA with a US marshall carrying an inspection warrant visit?

Refusals, etc., just make FDA look at more records and camp out at the firm longer (especially during for cause inspections or investigations).

If you have SOPs, you should make "How to Respond to an Audit" one of your SOPs. That way, no matter who gets the door, that person can sit the auditor(s) in the waiting area, check the SOP, and follow the procedure.

My organization does have this as a procedure, but I'd have to ask permission to share it, so let me know if you are unable to get the information you need through any other channels.

Working for the FDA for over 20 years, FDA does not take kindly to inspection refusals or sample collection refusals (both either partial or total refusals). If the firm is in operation, then FDA can come knocking, no matter if top management is there or not. This is not an excuse for a refusal- because the fimm is in operation! If FDA is refused (or is kept waiting for a while)(especially as a result of performing a compliance or for cause level III audit inspection or sample collection), problems will occur! Why would a firm want to have FDA with a US marshall carrying an inspection warrant visit?

Refusals, etc., just make FDA look at more records and camp out at the firm longer (especially during for cause inspections or investigations).

Welcome back Geochaz :bigwave: