http://blog.assurx.com/2009/10/05/the-most-common-drug-and-device-gmp-483-items/ Compliance, quality and risk: Straight talk for regulated industries Tue, 07 Feb 2012 22:43:09 +0000 hourly 1 http://wordpress.org/?v=3.3.1 http://blog.assurx.com/2009/10/05/the-most-common-drug-and-device-gmp-483-items/#comment-9811 Protect Your Firm as FDA Inspections Spike for CROs, Sponsors Tue, 24 May 2011 13:49:31 +0000 http://blog.assurx.com/?p=1103#comment-9811 [...] Do a search for your competitors’ recent FDA inspections and you will see the trend I am describing.  Build quality into your system from the ground up and you will get quality product results.  Trying to retroactively validate electronic systems and equipment or implement late stage corrections will leave you vulnerable to 483 observations. [...] [...] Do a search for your competitors’ recent FDA inspections and you will see the trend I am describing.  Build quality into your system from the ground up and you will get quality product results.  Trying to retroactively validate electronic systems and equipment or implement late stage corrections will leave you vulnerable to 483 observations. [...]

]]> http://blog.assurx.com/2009/10/05/the-most-common-drug-and-device-gmp-483-items/#comment-2395 Handling A Warning Letter: If At First You Don’t Succeed… Fri, 10 Dec 2010 17:56:35 +0000 http://blog.assurx.com/?p=1103#comment-2395 [...] year, we blogged about the most common drug and device GMP 483 items and how to respond to them in writing.  But what if your response is judged inadequate or the FDA [...] [...] year, we blogged about the most common drug and device GMP 483 items and how to respond to them in writing.  But what if your response is judged inadequate or the FDA [...]

]]> http://blog.assurx.com/2009/10/05/the-most-common-drug-and-device-gmp-483-items/#comment-150 Tony @FDAzilla.com Thu, 09 Sep 2010 03:58:07 +0000 http://blog.assurx.com/?p=1103#comment-150 We've got a searchable listing of all the 483s since 2000 here: http://www.fdazilla.com/fda/compliance/483/ We’ve got a searchable listing of all the 483s since 2000 here:
http://www.fdazilla.com/fda/compliance/483/

]]> http://blog.assurx.com/2009/10/05/the-most-common-drug-and-device-gmp-483-items/#comment-43 FDA Most Common Drug and Device 483 Items | Genome News Thu, 31 Dec 2009 04:51:59 +0000 http://blog.assurx.com/?p=1103#comment-43 [...] AssurXblog post, The Most Common Drug and Device GMP 483 Items, reports 6 common FDA GMP drug 483 items, and 5 common FDA GMP medical device 483 [...] [...] AssurXblog post, The Most Common Drug and Device GMP 483 Items, reports 6 common FDA GMP drug 483 items, and 5 common FDA GMP medical device 483 [...]

]]> http://blog.assurx.com/2009/10/05/the-most-common-drug-and-device-gmp-483-items/#comment-42 FDA Most Common Drug and Device 483 Items | Medicalcenterinfo.com Blogs Wed, 30 Dec 2009 23:24:18 +0000 http://blog.assurx.com/?p=1103#comment-42 [...] AssurXblog post, The Most Common Drug and Device GMP 483 Items, reports 6 common FDA GMP drug 483 items, and 5 common FDA GMP medical device 483 [...] [...] AssurXblog post, The Most Common Drug and Device GMP 483 Items, reports 6 common FDA GMP drug 483 items, and 5 common FDA GMP medical device 483 [...]

]]> http://blog.assurx.com/2009/10/05/the-most-common-drug-and-device-gmp-483-items/#comment-41 FDA Goes On Long-Awaited Hiring Binge | AssurX blog Tue, 27 Oct 2009 17:01:18 +0000 http://blog.assurx.com/?p=1103#comment-41 [...] it’s important to remember something that’s not so likely to change, according to Roh. The most common drug GMP 483 items have been and probably will remain: Responsibilities and procedures of the Quality Control unit are not in writing, written procedures [...] [...] it’s important to remember something that’s not so likely to change, according to Roh. The most common drug GMP 483 items have been and probably will remain: Responsibilities and procedures of the Quality Control unit are not in writing, written procedures [...]

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