FDA Enforcement

Presented by: Teresa Gorecki, Practice Lead, Compliance Architects What is it Steven Covey said in “The 7 Habits of Highly Effective People?” “Begin with the

Attention life science quality and compliance professionals. Mark your calendars for this Thursday, August 18th at 2PM ET! Our colleague Teresa Gorecki is presenting with four

Risk is still an important issue, and the fundamental premise is that there is so much to do. The science is so complex. The regulatory

The FDA and other global regulators rely on reviews of data during inspections to determine whether a pharmaceutical or medical device manufacturer is operating within regulatory requirements and expectations.

Well-drafted, easy-to-understand quality records are crucial to helping pharmaceutical and medical device manufacturers navigate FDA inspection obstacles. The FDA relies heavily on information presented in

Risk management is an essential activity for regulatory compliance within pharmaceutical and medical device companies.  While it is often challenging for medical product manufacturers to

There are no FDA regulations governing writing quality or clarity. FDA Investigators will never note “poor writing” as a 483 observation or warning letter citation. But

Important DRAFT FDA Guidance issued today (dated 2/19/19 however) regarding "non-binding feedback" after FDA inspections of certain medical device establishments. Limited to statutory (FDARA 704)

On January 25, 2018, the United Stated Department of Justice under Attorney General Jeff Sessions reversed decades of accepted regulatory agency practice by substantially reducing

On Thursday, December 7, Deputy Assistant Attorney General Ethan P. Davis, US Department of Justice, Consumer Protection Branch, gave a speech at the Food and

Two months ago I posted in LinkedIn about a Popular Science article that unfairly characterized FDA’s regulatory process, and implied FDA tacitly agreed with a

The election of Donald Trump as President-Elect of the United States was, and continues to be, a watershed moment in the 200+ year American experiment.  

The following was included in our July email newsletter. There are many training sessions conducted each year by GMP Training Managers and company quality and

Opportunities and Risks for Dietary Supplement Companies for 2016 and Beyond 2015 is certainly ending with a bang.    As many of us industry insiders have

Early December is one of my favorite times of year. Coming off of Thanksgiving and looking forward to the end-of-year holidays, it’s when I get

I just posted a response on LinkedIn to a recent LinkedIn post by John R. Fleder  (from his firm's excellent FDALawBlog) surrounding FDA's inspectional authority

The following entry is an excerpt from a LinkedIn post that I responded to today. It pertains to FDA's authority to take photographs during inspections,

The September 12 edition of the industry newsletter QMN Weekly contained an article about objections voiced by the International Academy of Compounding Pharmacists (IACP) concerning

If you have any role within an FDA-regulated company, it is likely you are aware that the FDA has been much more focused on enforcement

The new Inspections Database (http://www.fda.gov/ICECI/EnforcementActions/ucm222557.htm) is a positive step by FDA to provide further transparency for the public (and likely their Congressional representatives!) regarding enforcement

This is an UPDATE to a post from May 2010. Please click this link for the original post. On Monday, June 21, Apple released the

Join the Center for Business Intelligence for a one-hour, information-packed webinar on managing FDA  inspections from a more aggressive FDA.   Now that pharmaceutical, medical device,

I’m struggling to find an answer to the following question:   If you were the owner of a company, how much would you spend, year over

THE FOLLOWING POST IS FROM FDANEWS.  For additional information, please see: Ensuring Supply Continuity for Medically Necessary Drug Products The ink is barely dry on

  Business Intelligence Solutions Interview with Jack Garvey FDA INSPECTION READINESS   March 2010 What are the biggest issues currently facing FDA-regulated companies when it

A review of FDA enforcement news over the last year should clearly demonstrate an important shift in approach by the FDA that the “cop” side of

If you are reading this now, you are probably in the middle of an enforcement crisis.   Responding to an FDA-483, Warning Letter, or in some

Byline 1/19/2010, Legal Times DOJ Undercover Sting Nets 22 in Large Scale Foreign Corrupt Practices Act Case If you are working in a senior legal,