FDA査察が実施された場合、指摘事項が何もない場合は良いが、指摘事項がある場合は、連邦食品医薬品化粧品法(FDC法)704(b)項
「査察官は指摘事項を文書で製造所に提示すること」に基づいて、査察の最後の講評時に、FDA Form 483が発行される。
483は一般には公開されない。 ただし情報公開法に基づき、有償で公開請求はできる。 またWarning Letterで483の内容に言及することが多い。 講評時の意見を査察官が考慮し、FDA Form 483の最終版を作成してくれるので、すでに改善した事項があれば説明すると良い。 誤解や説明の間違いを正す機会でもある。
FDA Form 483には「最終的な評価はFDAコンプライアンス部門で実施されるので、FDA Form 483は査察時の指摘事項としての報告である。」と記載されている。
![](https://ecompliance.co.jp/FDA/img/form483.jpg)
FDA Form 483フォームの調べ方
Warning LetterはFDAのホームページで公開されますが、483 Formは公開されません。
しかしながら、米国の情報公開法に基づき、有償で取り寄せることも可能です。
一部の483 Formは、サイトから購入することができます。
FDA Form 483を受取ったら
FDA Form 483により指摘された内容に対し、15営業日以内(必着)にレスポンスを送付すること。
早急な回答により、FDAは、企業がその期待を理解し、483を重大なことと受け止めていることを理解する。
FDA Form 483による指摘へのレスポンスは極めて詳細である必要はない。
レスポンスは査察を実施した査察官宛に送付するのではなく、FDA本部に送付することに注意。
改善策、スケジュールを盛り込んだFDA Form 483に対する回答を15作業日以内にFDAへ送ること。
次回査察時に改善実施について確認されるので、確実に改善ができることを書くこと。
机上の空論のようなことは書かないこと。
FDA Form 483の回答が不十分であれば、Warning Letterをもらうことになる。
FDA Form 483にはならなかったが、他に指摘点があれば、原因の究明、再発防止に手段を講じること。
後日FDAより送付されてくるEstablishment Inspection Report(EIR)の内容を確認すること。
FDA Form 483にはない詳しい情報が含まれている。
FDA査察の指摘事項(FDA Form 483)への回答期限について
FDAは、2009年8月発表のFederal Registerで、
「FDA査察の指摘事項(FDA Form 483)への回答期限を15日以内とする。Warning Letterを速やかに出せるようにするためである。2009年9月15日から実施する。」
と通知した。
FDA査察官がFDA Form 483を発行した場合、改善策、スケジュールを盛り込んだ回答を15日以内にFDA必着で郵送しなければならない。
理由の如何を問わず、FDA Form 483への回答が15日以内にFDAに届かない場合は、Warning Letterが発行されることになる。
日本企業においても、過去に15日以内に指摘事項への回答が15日以内にFDAに届かなかったため、Warning Letterが発行された企業が数社見受けられる。
また、FDA Form 483の回答が不十分であったり、不適切であると判断された場合も、Warning Letterが発行される。
あるデンマークの企業は、改訂したSOPをデンマーク語でFDAに送付したために、Warning Letterが発行された。
FDAは「デンマーク語でレビュできないためである」ということであった。
別のドイツの企業は、FDA査察官の指摘事項をデータベース化し、改善状況をオンラインでFDAがレビュできるようにした。
FDAにアカウント情報を通知したところ「我々はあなたの企業のシステムにログオンするつもりはない。」といったWarning Letterが発行された。
回答書は、査察を実施した査察官宛に送付するのではなく、FDA本部に送付することに注意が必要である。
FDA Form 483には「最終的な評価はFDAコンプライアンス部門で実施されるので、FDA Form 483は査察時の指摘事項としての報告である。」と記載されている。
つまり査察官によっては、専門分野や考え方などから、指摘事項が企業毎に異なることが多く、不公平が生じるため、FDA本部が指摘事項を見直すのである。
筆者がコンサルテーションを実施した企業においても、査察官が指摘を9件発行したが、後にFDA本部が指摘ゼロに変更した事例がある。
しかしながら、15日以内にはFDA本部の最終決定は出ないため、いずれにせよ査察官の指摘に対応せざるを得ない。
FDA Form 483による指摘への回答は極めて詳細である必要はない。
次回査察時に回答書に記載した改善実施について確認されるので、確実に改善ができることを書くこと。机上の空論のようなことは書いてはならない。
また後日(かなり時間がかかるが)Establishment Inspection Report(EIR)がFDAから送られてくる。EIRは、査察官の議事録のようなもので、FDA Form 483にはない詳しい情報が含まれている。
次回査察時における参考になる。
![](https://ecompliance.co.jp/FDA/img/information.jpg)
Mike Oreon https://ijrfpioqqerjw.com 123
Unquestionably imagine that that you stated. Your favorite justification seemed
to be on the net the easiest factor to consider of. I say to you, I certainly get irked even as other people
consider worries that they plainly do not recognise about.
You controlled to hit the nail upon the top and also outlined
out the whole thing without having side effect , folks can take a signal.
Will probably be back to get more. Thanks
you’re really a just right webmaster. The web site loading speed is incredible.
It sort of feels that you are doing any distinctive
trick. Furthermore, The contents are masterpiece. you have done
a magnificent process on this matter!
Thank you for the good writeup. It in fact was a amusement account it.
Look advanced to more added agreeable from you! However, how
can we communicate?
I have to thank you for the efforts you have put in writing this blog.
I really hope to view the same high-grade content by you later on as well.
In fact, your creative writing abilities has encouraged me to get my very own blog now 😉
Truly when someone doesn’t understand afterward its up to other users that they will help, so here it occurs.
It’s going to be ending of mine day, but before end I am reading this enormous
piece of writing to increase my experience.
Wow that was odd. I just wrote an extremely long comment but after I clicked submit my comment didn’t appear.
Grrrr… well I’m not writing all that over again. Anyways, just wanted to say excellent blog!
Hi would you mind stating which blog platform you’re using?
I’m planning to start my own blog in the near future but I’m having
a difficult time choosing between BlogEngine/Wordpress/B2evolution and Drupal.
The reason I ask is because your design seems different then most blogs and I’m looking for something unique.
P.S Apologies for getting off-topic but I had to ask!
Awesome blog! Is your theme custom made or did you download it from somewhere?
A theme like yours with a few simple adjustements would really make my blog shine.
Please let me know where you got your theme. Thanks
I’m truly enjoying the design and layout of your blog.
It’s a very easy on the eyes which makes it much more enjoyable for
me to come here and visit more often. Did you hire out a designer
to create your theme? Fantastic work!
Tremendous things here. I am very happy to look your post.
Thanks so much and I am taking a look ahead to contact you.
Will you please drop me a mail?
Wonderful beat ! I would like to apprentice whilst you
amend your web site, how could i subscribe for a weblog site?
The account aided me a appropriate deal. I were a little bit acquainted of this your broadcast offered vibrant transparent concept
I used to be able to find good information from your blog articles.
Hurrah! At last I got a blog from where I know how
to genuinely obtain valuable facts regarding my study and knowledge.
Hi! Do you use Twitter? I’d like to follow you if that would be
okay. I’m absolutely enjoying your blog and look forward to new updates.
My spouse and I stumbled over here different web page and thought
I should check things out. I like what I see so now i am following you.
Look forward to looking into your web page for a second time.
Wow, this paragraph is good, my sister is analyzing these things, so I am going to let know her.
What’s up, the whole thing is going well here
and ofcourse every one is sharing data, that’s genuinely excellent, keep up writing.
magnificent post, very informative. I wonder why the other experts of this sector do not
realize this. You must proceed your writing.
I am sure, you’ve a great readers’ base already!
This is a topic that is close to my heart… Thank you!
Exactly where are your contact details though?
I was suggested this website by my cousin. I’m not sure whether this
post is written by him as no one else know such detailed about my difficulty.
You are incredible! Thanks!
Thanks a bunch for sharing this with all of us you actually realize what you
are speaking about! Bookmarked. Please additionally talk over with my website =).
We may have a link exchange contract among us
This design is wicked! You definitely know how to keep a reader entertained.
Between your wit and your videos, I was almost moved
to start my own blog (well, almost…HaHa!) Wonderful job. I really
loved what you had to say, and more than that, how you presented it.
Too cool!
What a stuff of un-ambiguity and preserveness of precious know-how concerning unexpected emotions.
I was suggested this blog by my cousin. I am not sure
whether this post is written by him as nobody else know such detailed about my problem.
You are incredible! Thanks!
Excellent web site. Lots of helpful information here.
I’m sending it to a few pals ans also sharing in delicious.
And naturally, thank you to your sweat!
I’m really loving the theme/design of your web site.
Do you ever run into any web browser compatibility issues?
A few of my blog visitors have complained about my website
not working correctly in Explorer but looks great in Safari.
Do you have any advice to help fix this problem?
What’s Taking place i am new to this, I stumbled upon this I’ve found It positively helpful and it has helped me out loads.
I am hoping to give a contribution & aid different users like
its helped me. Good job.
Wow, superb blog structure! How long have you ever been blogging for?
you made running a blog glance easy. The whole look of your site is magnificent, let alone the content!
Very good info. Lucky me I recently found your blog by chance
(stumbleupon). I’ve book-marked it for later!
I’m excited to uncover this site. I need to to thank you for ones time for this wonderful read!!
I definitely enjoyed every bit of it and i also have you bookmarked to check out new things in your web site.
I think that what you wrote was very logical. But, what
about this? what if you composed a catchier post title?
I ain’t saying your information is not good., however what if you added a title to maybe
grab a person’s attention? I mean Form FDA 483とは | お役立ち情報 is kinda boring.
You might glance at Yahoo’s home page and note how they create post titles
to get viewers interested. You might add a video or a picture or two to grab readers
interested about what you’ve written. Just my opinion, it would bring your blog a little livelier.
Thanks for sharing your thoughts about ufo5555. Regards
It’s very simple to find out any matter on net as compared to textbooks, as I found
this piece of writing at this website.
Hi, I read your blog regularly. Your humoristic style is witty, keep up the good work!
I enjoy what you guys are up too. This sort of clever work
and reporting! Keep up the awesome works guys I’ve added you guys to my own blogroll.
Very good article! We are linking to this great content on our website.
Keep up the great writing.
Oh my goodness! Amazing article dude! Thank you, However I am having troubles
with your RSS. I don’t know the reason why I am unable to subscribe to it.
Is there anyone else getting the same RSS issues?
Anyone who knows the answer can you kindly respond?
Thanx!!
It’s a pity you don’t have a donate button! I’d without a doubt donate
to this outstanding blog! I guess for now i’ll settle for
book-marking and adding your RSS feed to my Google account.
I look forward to new updates and will talk about this site with my Facebook group.
Talk soon!
Very energetic blog, I liked that bit. Will there be a part 2?
I have been browsing online more than three hours today,
yet I by no means discovered any fascinating article like yours.
It is lovely value enough for me. In my view, if all site owners
and bloggers made good content as you probably did, the net will probably
be a lot more helpful than ever before.
It’s awesome how wonderfull this site is Get more info
Write more, thats all I have to say. Literally, it seems as though you relied on the video to make your point.
You obviously know what youre talking about, why waste your intelligence on just posting videos to your weblog when you could be giving us
something informative to read?
Hey! Would you mind if I share your blog with my facebook
group? There’s a lot of folks that I think would really appreciate
your content. Please let me know. Thank you
These are truly wonderful ideas in regarding blogging.
You have touched some pleasant points here. Any
way keep up wrinting.
Hi, i think that i saw you visited my blog thus i came
to “return the favor”.I am attempting to find things to improve my website!I suppose its
ok to use some of your ideas!!
Does your blog have a contact page? I’m having problems locating
it but, I’d like to shoot you an e-mail. I’ve got some suggestions for your blog you might be interested in hearing.
Either way, great site and I look forward to seeing it improve over time.
It’s awesome how illustrative this site is Get more info
Saved as a favorite, I really like your site!
I like the helpful information you supply for your
articles. I’ll bookmark your weblog and test once more right here regularly.
I’m moderately sure I will be informed plenty
of new stuff proper right here! Best of luck for the next!
An interesting discussion is definitely worth comment.
There’s no doubt that that you should write more about this
issue, it may not be a taboo matter but generally people don’t discuss
these subjects. To the next! All the best!!
You cannot get enough of this Get more info
You actually make it seem so easy with your presentation but I find this topic to be actually something which I think I would never understand.
It seems too complicated and extremely broad for me.
I’m looking forward for your next post, I’ll try to get the hang of it!
Great delivery. Solid arguments. Keep up the amazing effort.
It’s a shame you don’t have a donate button! I’d certainly donate to this
excellent blog! I suppose for now i’ll settle for book-marking and
adding your RSS feed to my Google account.
I look forward to new updates and will talk about this website with
my Facebook group. Chat soon!
Excellent post. I was checking continuously this weblog
and I am impressed! Very useful info specially the remaining part :
) I deal with such info a lot. I used to be seeking this particular information for
a long time. Thanks and good luck.
I’m curious to find out what blog platform you have been using?
I’m experiencing some small security problems with my latest site and I would like to find something
more risk-free. Do you have any recommendations?
I do not know whether it’s just me or if perhaps
everyone else experiencing problems with your website.
It looks like some of the text in your content are running off the screen. Can somebody else please provide feedback
and let me know if this is happening to them too?
This may be a issue with my browser because I’ve had this
happen before. Many thanks
This is very interesting, You’re a very skilled blogger.
I’ve joined your rss feed and look forward to seeking more of your great
post. Also, I have shared your website in my social networks!
Hey there! Would you mind if I share your blog with
my twitter group? There’s a lot of people that I think would really appreciate your content.
Please let me know. Cheers
I’ve noticed that certain models provide superior accuracy over others, depending on their use
case.
Current sensors provide valuable data for tracking electrical systems.
Are there any brands you trust for accuracy?
Visit my website; Versatile Current measurement components
Everyone loves it when individuals get together and share views.
Great site, stick with it!
Hi are using WordPress for your blog platform? I’m new to the blog world but I’m trying to get started
and set up my own. Do you require any coding expertise to make your own blog?
Any help would be greatly appreciated!
Environmental issues are at forefront of a variety of industries, including the stainless steel sector is not an exception. I’ve been studying the life-cycle
assessment of stainless steel products, which has yielded results that are positive.
The high recycling rate as well as the lengthy
service life of stainless steel objects is a significant factor in reducing the environmental impact
of the material.
excellent points altogether, you just received a brand new reader.
What might you suggest in regards to your submit that you made some
days in the past? Any positive?
Howdy! I could have sworn I’ve visited this blog before but after browsing through many of the posts I
realized it’s new to me. Anyhow, I’m definitely delighted I found it and I’ll be book-marking it
and checking back often!
It’s awesome how wonderfull this site is Get more info
It’s awesome how wonderfull this site is Get more info