I just received an email notification from FDA regarding "3rd Part Facility Inspections". Just so I understand, why would it be in a manufacturer's best interest to "invite" a facility inspection? I see how FDA clearly benefits by outsourcing this task, but why would a device manufacturer, of their own volition, actually invite an inspection? Is the assumption that if a manufacturer is "overdue" on their 2-year inspection rotation that they "invite" A 3rd party inspector? Perhaps there is something I am missing about how the program works & if so I'd appreciate being set straight!

I just received an email notification from FDA regarding "3rd Part Facility Inspections". Just so I understand, why would it be in a manufacturer's best interest to "invite" a facility inspection? I see how FDA clearly benefits by outsourcing this task, but why would a device manufacturer, of their own volition, actually invite an inspection? Is the assumption that if a manufacturer is "overdue" on their 2-year inspection rotation that they "invite" A 3rd party inspector? Perhaps there is something I am missing about how the program works & if so I'd appreciate being set straight!Unless you share the text of the FDA email, it will be hard to provide meaningful feedback, but one of the possible benefits for medical devices manufacturers under both FDA and Health Canada oversight is to be assessed once (by a qualified third-party) and have the assessment results recognized by both regulatory agencies.

Dear Class II & III Medical Device Manufacturers:
The purpose of this letter is to update you on the current status of the U.S. Food and Drug Administration’s (U.S. FDA) Accredited Persons (AP) for Inspection Program. Since first implemented with the passage of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the FDA has accredited 16 organizations, conducted classroom training for over 60 AP auditors, and participated in joint inspections/audits with over 40 AP auditors. Currently there are 9 AP auditors among 8 APs that are fully qualified to conduct independent inspections on behalf of the U.S. FDA. Still there has been relatively low participation by the medical device industry in this program.
To encourage participation, the U.S. Congress recently amended the Federal Food Drug and Cosmetic Act to streamline the AP for Inspection program. These amendments to the act will ease the requirements to use an AP by industry for their FDA inspection. Today it is no longer necessary to obtain prior FDA approval to use a qualified AP. The steps are simple:
1. Select qualified AP from the U.S. FDA AP for Inspection Webpage (http://www.fda.gov/cdrh/ap-inspection/index.html) and discuss device review and associated fees with AP;
2. Send letter to FDA stating your intention to us an AP to conduct your establishment inspection;
3. Provide date of the last inspection and the inspection classification;
4. Identify the AP intended to be used;
5. Certify that your establishment produces at least one domestically marketed device, and one device is exported or intended to be exported to a country that recognizes the AP intended to be used.

If you wish to use a fully qualified AP auditor to conduct your FDA inspection, please send the requested information above to Mr. David Kalins in FDA’s Center for Devices and Radiological Health (CDRH) Office of Compliance (OC) at the following address:
Accredited Persons Program Coordinator
Office of Compliance – HFZ-300
9200 Corporate Blvd.
Rockville, MD 20850
Alternatively, electronic submissions may be made to Mr. Kalins by email at: david.kalins@fda.hhs.gov.
In addition, FDA is still working to qualify additional auditors to participate in the Third Party AP for Inspection program. This will increase the number of APs with qualified auditors and thus increase the pool of APs that industry may select from to perform independent inspections. To do so, we need industry volunteers who are eligible to participate in this program to allow FDA to use their sites during an upcoming inspection as training opportunities for prospective AP’s. To qualify as an AP auditor, these individuals must participate in a three tiered audit program with FDA to demonstrate their knowledge and ability to apply the classroom training they have received. The Conformity Assessment Body (CAB) or Notified Body (NB) that you currently employ may have auditors awaiting their qualifying inspection under the AP program. Please look for your CAB or NB at FDA’s Third Party web site: http://www.fda.gov/cdrh/ap-inspection/index.html. If the firm lacks an asterisk, then they currently DO NOT have a qualified auditor. Contact your CAB or NB and discuss hosting an audit for one of their auditors. We welcome eligible firms who are willing to offer their services, and request that you contact Mr. James Dunnie in FDA’s Office of Regulatory Affairs by E-mail at: james.dunnie@fda.hhs.gov or telephone at (301) 827-5652.
Together we can demonstrate our support and commitment to this important program. The benefits to industry will also save both time and resources by having one inspectional visit cover multiple regulatory requirements; fewer total annual surveillance inspections; and the ability to schedule inspections at times most convenient to your business rather than when FDA plans to schedule them.
If you have any general questions regarding this program, please contact Mr. William Sutton, Chairman of FDA’s Third Party Recognition Board (TPRB) at: william.sutton@fda.hhs.gov or by telephone at 1-800-638-2041 ext. 125.
Sincerely yours,
John Stigi
Director
Division of Small Manufacturers, International and Consumer Assistance
Center for Devices and Radiological Health
U.S. Food and Drug Administration

The "relatively low participation by the medical device industry" in the APIP program seems to be a rather clear indication that most device makers don't care to increase their regulatory compliance costs.

Seems to be one of the programs where several CB's decided to join, certainly invested a good chunk of money and, here we are, several years later, only 9 people (from 8 CB's) have been (independently) approved to perform the assessments (I refuse to use the word inspection), and still, the manufacturers don't see the benefits of "inviting" anyone to perform the work. Surely, someone must be pushing some buttons with the FDA to get this ball rolling. After all, investments were made. People want a return.

Interesting also to note that one of the CB's listed as approved for the FDA program was disqualified from the Canadian program.

Apart from cost...what about freqency of inspections? One never "requests" an facility inspection directly from the Agency. Why would that change just because there was a 3rd party inspector available?

My understanding of some arguments in favor of using APIP:

1. Within the general FDA inspection frequency-guidelines, it provides control of specifically when you're audited. (But only for two QSIT-equivalent audits, after which FDA must do at least one inspection.)

2. It provides a means to obtain a timely FDA-equivalent inspection/audit if such is needed to qualify for certain other-nation regulatory statuses that are dependent on being able to show evidence of a recent satisfactory FDA inspection. (I've been told this, but don't have further knowledge of exactly what that status might be.)

3. If a company has a good, productive relationship with their ISO audit body in regard to auditor personnel, it allows them to extend that productive relationship and minimize the possibility that they might have the bad luck of being inspected by FDA personnel with whom they "get off on the wrong foot".

4. Similarly to (3), if a company has an unusually complex or historically problematic quality system, production situation or product family, it allows them to work exclusively with an ISO audit team that has already learned the issues and history involved, rather than having the FDA inspect them without benefit of that prior education. (Though this advantage is only available for firms that have a sufficiently good record that they're eligible for the QSIT inspection program.)

Important point 1 (my emphasis added):
Currently there are 9 AP auditors among 8 APs that are fully qualified to conduct independent inspections on behalf of the U.S. FDA.

Read: Let somebody else do this.

Important point 2 (my emphasis):

The benefits to industry will also save both time and resources by having one inspectional visit cover multiple regulatory requirements; fewer total annual surveillance inspections; and the ability to schedule inspections at times most convenient to your business rather than when FDA plans to schedule them.

The sell job.

The rest was filler. :cool:

We were skeptical at first, with our VP pushing for this audit. My VP was ex-fda (10 years). He invited participation in this program as a strategy we couldn't figure out until it was over. We volunteered in this program and had a 3rd party auditor fly in, who was accompanied by an FDA auditor known to be very tough.

We got off REALLY EASY!! What a great strategy! He knew the 3rd party would not be able to find anything significant. We got away with 1 write up after the FDA finally took over towards the end of the week when she got tired of the 3rd party auditor falling asleep during the audit.

If it is solely a 3rd party, we would have gotten off scott free.

I would recommend the 3rd party route if you are worried about the state and compliance of your quality system, as our company was.

when she got tired of the 3rd party auditor falling asleep during the audit.Maybe s/he was meditating...:tg:

That is why ISO 19011 suggests people who suffer from narcolepsy don't make for good auditor candidates...:lmao:

Ummm...I'm not sure if I want to know who the auditor is with or not.

I sure wouldn't want us, or our key customers or suppliers, doing business with them.

That's about the worst slam of APIP I can possibly think of...the participant signs up an incompetent individual and sends them out on jobs, and the FDA has someone on the spot observing the incompetence and doesn't throw them out and start the inspection over. Yikes. :rolleyes:

Ummm...I'm not sure if I want to know who the auditor is with or not.

I sure wouldn't want us, or our key customers or suppliers, doing business with them.

That's about the worst slam of APIP I can possibly think of...the participant signs up an incompetent individual and sends them out on jobs, and the FDA has someone on the spot observing the incompetence and doesn't throw them out and start the inspection over. Yikes. :rolleyes:


In this particular instance, the AP auditor was being observed by FDA to determine if they were eligible for meeting the criteria for being an APIP auditor...obviously, since she took over on Thursday:lol:, he failed to meet the criteria. I observed some of the audit and the 3rd party auditor was really into the audit until it came to complaints and CAPA...at which time he dozed off, right before my very eyes. He was from Korea, I think his name was Soon Gon (we just referred to him as Soon Be Gone). The FDA auditor was not very happy. She didn't want to come back for another week with Soon Be Gone, so she ended the audit on Friday...Thank goodness! She could have slaughtered us!

The good news is that we got off easy, the bad news is that the audit was a disservice for support of compliance in our company and an embarrassment for FDA.