For companies registered with the FDA, you can check the FDA’s inspection database to see the specific firms compliance status (NAI, VAI, or OAI) – https://www.fda.gov/iceci/inspections/ucm222557.htm. I prefer starting here as it gives me a picture of their status over time. You can also go to the FDA ORA FOIA electronic reading room and can find frequently requested 483s – https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/default.htm. These two tactics augment looking through the warning letters. I also check the EMA Eudra GMP/GDP database for non compliance reports – http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPNonCompliance.do. Some companies use RX360 audits as part of their program – http://rx-360.org/.
15 thoughts on “Get copy of 483’s, Non-compliance report and GMP certificate online from Agencies”
Leave a Reply Cancel reply
You must be logged in to post a comment.
Ahaa, its good dialogue concerning this post at this place at this website, I have read
all that, so at this time me also commenting here.
It is the best time to make some plans for the future and it is
time to be happy. I’ve read this post and if I could I wish to suggest you some interesting things
or advice. Perhaps you can write next articles referring to
this article. I wish to read more things about it!
May I simply just say what a relief to uncover somebody who truly knows what they are
talking about on the web. You definitely realize how to bring a
problem to light and make it important. A lot more
people ought to look at this and understand
this side of the story. I can’t believe you aren’t
more popular given that you definitely possess the gift.
Aw, this was a really nice post. Finding the time and actual effort
to produce a top notch article… but what can I say…
I procrastinate a lot and don’t seem to get nearly anything done.
Hello there! I could have sworn I’ve visited this web site before but
after going through some of the posts I realized
it’s new to me. Anyhow, I’m definitely happy I discovered it and
I’ll be bookmarking it and checking back frequently!
Please let me know if you’re looking for a article
author for your site. You have some really good posts and I think I would be a
good asset. If you ever want to take some of the load off, I’d really like
to write some content for your blog in exchange for a link back to mine.
Please blast me an email if interested. Thank you!
We can connect. Please note my mail id: palash.ds@gmail.com
If some one wishes to be updated with latest technologies
then he must be visit this website and be up to date everyday.
I visited various web pages except the audio quality for audio songs present at this site is in fact
wonderful.
I got this website from my buddy who informed me regarding this website and now this time I am
visiting this website and reading very informative content here.
Touche. Solid arguments. Keep up the amazing work.
That is really fascinating, You are an excessively professional blogger.
I’ve joined your feed and look ahead to searching
for more of your wonderful post. Additionally, I have shared your
website in my social networks
Hi, i read your blog occasionally and i own a similar one and i was just wondering if you get a lot of spam responses?
If so how do you protect against it, any plugin or anything you can suggest?
I get so much lately it’s driving me mad so any support is very much appreciated.
Excellent blog here! Also your web site loads up fast!
What web host are you using? Can I get your affiliate link to
your host? I wish my web site loaded up as fast
as yours lol
Thanks for some other great article. Where else may just anybody get that kind of information in such an ideal manner of writing? I’ve a presentation subsequent week, and I am at the look for such information.