FDA Consent Decree

25 08, 2016

The Story of 3 Consent Decrees

By | 2018-04-26T13:31:39+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 [...]

25 03, 2015

We Learned 5 Things from 2014 FDA and EU GMP Drug Enforcement Actions

By | 2017-11-06T01:19:57+00:00 March 25th, 2015|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA, FDA Consent Decree, FDA Inspections, Form FDA 483, Medical Devices|

2014 proved to be another busy year for the FDA.  We asked Barbara Unger, President of Unger Consulting and Editor-in-Chief of GMP Regulatory Intelligence, to summarize her key take-aways from the enforcement actions of the FDA and EU in 2014. Here’s Barbara: […]