Form FDA 483

12 03, 2018

[UPDATED] Interval Between Inspection and Warning Letters Decreasing

By | 2018-03-12T12:55:54+00:00 March 12th, 2018|Biopharma / Pharma, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, Form FDA 483|

A blog entry that evaluated FDA enforcement actions in the first half of FY2016 provided data to demonstrate that the interval between GMP drug inspections and warning letters almost doubled since FY2013. The relevant table and graph is provided below. We’ve been watching this trend for the past couple of years, and now we are seeing the reverse—the interval [...]

7 03, 2018

75 New FDA 483s | March 7th 2018

By | 2018-03-07T15:52:28+00:00 March 7th, 2018|Biopharma / Pharma, FDAzilla, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

This past week, we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. 483 3M Company Milford  Nov 2015 483 Accupack Midwest Cincinnati  Oct 2012 483 Advanced Interventional Pain Ctr IRB Lafayette  Oct 2013 483 AdvancePierre Foods Amherst  Mar 2011 483 Agnes E. Ubani, [...]

27 02, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 2/18/18

By | 2018-02-27T12:14:29+00:00 February 27th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Warning Letters, FDAzilla, Form FDA 483, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers The FDA issued a collection of guidance the week of February 18th regarding devices, safety, clinical ICH Quality, and administrative items. WHO and TGA each published two new guidance. It was a busy week on the publication front. To see the complete list of laws, regulations, guidance, and concept papers published this week, [...]

22 02, 2018

5 Ways Manufacturing Quality Problems Can Take Down a Company

By | 2018-02-22T17:26:09+00:00 February 22nd, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, FDA-Regulated Industry, Food, Form FDA 483, Medical Devices|

Manufacturing quality issues arise from time to time at pharmaceutical, medical device, and food companies, and if left unchecked, can lead to massive losses. Analyzing FDA inspections and a company's performance provides early insights into any potential issues that may be brewing. Almost all quality-related warning letters start with an inspection and a 483. While some warning letters result [...]

20 11, 2017

Deep Pockets | Does the FDA Get Tougher if the Owner Gets Richer?

By | 2018-02-14T12:13:07+00:00 November 20th, 2017|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement Trends, FDA-Regulated Industry, FDAzilla, Form FDA 483, MOST POPULAR, Pharma - Featured|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Acquisition of one pharmaceutical firm by another is preceded by due diligence efforts in many functional areas.  Let’s talk about activities in the GMP area.  Firms may not be able to fully rely on past inspections by the FDA to predict the extent of remediation that might be necessary [...]

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 [...]