Form FDA 483

10 05, 2017

When Will the FDA Move On from Data Integrity?

By | 2017-11-06T01:19:57+00:00 May 10th, 2017|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA, FDA Inspections, FDAzilla, Form FDA 483, quality assurance|

The FDA has been writing up companies on data integrity since the year 2000. Even after all the horror stories, and even after billions of dollars of market cap have been erased from it, here we are in 2017, still talking about it. Here is some troubling text from recent Warning Letters that cite data integrity: “…our investigator observed your [...]

17 04, 2017

Why is No One Talking About This? 2016 was the Year the FDA Exploded on China

By | 2017-04-19T10:38:31+00:00 April 17th, 2017|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA, FDA Inspections, Form FDA 483|

New data synthesized by FDAzilla has revealed several dramatic shifts with FDA inspection and enforcement activity. The FDA issued 15 pharma GMP-related warning letters to manufacturing sites in China in 2016 – a 5-fold increase from years prior. China averaged 2.7 Warning Letters per year from 2013 to 2015.  This explosion was led mostly by infamous FDA investigator, Peter Baker, who [...]

23 11, 2016

Inspect your FDA Inspector Before Your Inspection

By | 2017-06-30T12:27:13+00:00 November 23rd, 2016|CGMP, cGMP Quality Assurance and FDA 483s, FDA Inspections, Form FDA 483, quality assurance|

Today, I’m excited to officially announce a new set of services to help you prepare for your next FDA inspections – FDA Inspector Profiles. We’ve taken 16+ years of FDA inspection data and combined it with other relevant databases to bring you a comprehensive, detailed look into any individual FDA Inspector. […]

25 08, 2016

The Story of 3 Consent Decrees

By | 2017-11-06T03:31:56+00:00 August 25th, 2016|CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Inspections, Form FDA 483, quality assurance|

by Barbara Unger, FDAzilla GMP Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence A consent decree agreement is an agreement filed in the US courts formalizing a voluntary agreement between two parties.  Here we will address consent decree agreements between FDA and several pharmaceutical companies based on repeated failures to adequately address CGMP deficiencies.  It is not an action taken [...]

18 08, 2016

A Bad 483 Could Cost A Company Millions

By | 2018-02-14T12:06:45+00:00 August 18th, 2016|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Inspections, Form FDA 483, MOST POPULAR|

“Forget about actual warning letters. The cost of us receiving a moderately bad 483 is roughly $250,000.” I heard this from a reputable Head of Manufacturing of one of the largest biopharma companies in the world.  While most pharma and med device companies seems to learn quickly from everyone else’s mistakes, companies still occasionally get a “moderately bad” 483.  And then [...]

5 08, 2016

5 FEATURES TO LOOK FOR IN AN EIR

By | 2017-11-06T03:46:05+00:00 August 5th, 2016|cGMP Quality Assurance and FDA 483s, FDA Inspections, FDAzilla, Form FDA 483, quality assurance|

Benjamin Franklin said, “By failing to prepare, you are preparing to fail.”  Prepare for your FDA inspections with Establish Inspection Reports (EIR).  An EIR is the full report of an FDA inspection written by the investigators.  Among the features identified in the report are: […]

28 07, 2016

FDAzilla’s Top 14 Posts of all Time

By | 2017-11-06T03:51:19+00:00 July 28th, 2016|cGMP Quality Assurance and FDA 483s, Form FDA 483|

Over the years, the FDAzilla blog has published almost 300 articles. We’ve acquired a lot of new readers since we started writing here in 2010. With these newer followers in mind, FDAzilla has assembled a list of some of our most useful articles. To put together this collection, we considered which posts have been the most searched-for and viewed over time, and evaluated these popular posts for [...]