Category Archives: FDA

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

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 performed 17 inspections in China in 2016, leading to 13 FDA Form 483s and 4 Warning Letters. Continue reading

Delay, Denial, or Limiting of Inspections Since 2008

Delay, Denial, or Limiting of Inspections Since 2008

by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief

In October 2014, the FDA published a final Guidance for Industry, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection. Publishing this guidance was a requirement of section 707 of the Food and Drug Administration Safety and Innovation Act (FDASIA).  Section 707 of FDASIA adds 501(j) to the Food, Drug, and Cosmetic Act (FD&C Act) to deem a drug adulterated if it “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.”  Before that time and since, the FDA cited instances where firms have delayed inspections or denied investigators access to areas or documents that they should be able to view.

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What is the Future of Outsourcing Facilities?

What is the Future of Outsourcing Facilities?

by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief

PART II Policies, Enforcement, and Predictions

Policies:
In this section, we will address policies and guidance that the FDA has published since the end of 2013, look at enforcement activities in this area, and make some predictions for the future of this market segment.

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FDA and MHRA MOST RECENT INSPECTION OBSERVATIONS

FDA and MHRA MOST RECENT INSPECTION OBSERVATIONS

by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief

INTRODUCTION:

Part of a comprehensive GMP Intelligence program is the monitoring of enforcement actions, including FDA 483s, warning letters, recalls, import alerts, consent decree agreements, and EU reports of GMDP noncompliance. This article presents the most recent GMP inspection data from CDER and MHRA.  The CDER data are from inspections conducted in FY2016 and the MHRA data come from inspections conducted in 2015.

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Outsourcing Facilities: Are They Still Worth It and Were They Ever?

The Real Story Behind Outsourcing Facilities:

Are They Still Worth It and Were They Ever?

by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief

PART I History and Background:

The New England Compounding Center (NECC) preparation and shipment of contaminated injectable products across state lines in 2012 created a firestorm of publicity and enforcement actions.  More than 750 patients in twenty states developed a fungal infection, fungal meningitis, and more than 60 people died.  Others became sick and suffered long term harm as reported by Kurt Eichenwald in a Newsweek article of April 2015.   In an abundance of caution, FDA quickly recommended that healthcare providers not use any product from NECC.  The FDA commissioner gave testimony before Congress in November 2012 where they outlined their response and presented FDA’s legal authority over compounded drugs.  In December 2014 fourteen arrests were made.  The owner of the pharmacy was indicted by a federal grand jury and is currently on trial.  He faces racketeering charges and twenty-five counts of second decree murder.  In May 2015, a federal bankruptcy judge approved a $200 million fund to provide compensation to victims. A recent article from the Wicked Local Framingham written by Walter F. Roche Jr., identifies some of the practices that have come to light at the trial.   This event triggered legislative changes, development of more than two dozen guidance documents, and changes in inspection practices for a niche area of drug preparation within the United States.

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Warning Letters

FDA Sent These 10 Warning Letters for Pharma Companies | January 2017

We took a snapshot of the 10 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from products not meeting “the definition and standard for chocolate” to sites “refusing to permit the FDA inspection” altogether.

From pharmaceuticals in Italy, Pennsylvania, and more, here they are (starting with the most recent):
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Warning Letters

FDA Sent These 5 Warning Letters for Pharma Companies | December 2016

We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to put expiration dates on containers to failing to put soap in the bathrooms.

From pharmaceuticals in Canada, Spain, and more, here they are (starting with the most recent):
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Warning Letters

FDA Sent These 7 Warning Letters for Pharma Companies | November 2016

We took a snapshot of the 7 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to maintain complete data to failing to prevent microbiological contamination.

From pharmaceuticals in Japan, New Jersey, and more, here they are (starting with the most recent):
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Warning Letters

FDA Sent These 6 Warning Letters for Pharma Companies | October 2016

We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from allowing unauthorized access to confidential data to forgetting to put expiration dates on drugs.

From 3 pharmaceuticals in the USA and 3 abroad, here they are (starting with the most recent):
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Warning Letters

FDA Sent These 8 Warning Letters for Pharma Companies | September 2016

We took a snapshot of the 8 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from a product containing “hair and a black spider” to management failing to “document laboratory controls.”

From pharmaceuticals in Japan, Brazil, and more, here they are (starting with the most recent):
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Warning Letters

FDA Sent These 13 Warning Letters for Pharma Companies | August 2016

We took a snapshot of the 13 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to “maintain written records” to failing to wear “clothing appropriate to protect drug product.”

From pharmaceuticals in Brazil, India, China, and 6 US states, here they are (starting with the most recent):
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3 Key Learnings from the PDA/FDA Joint Conference

by Barbara Unger, FDAzilla GMP Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence

OVERALL:  This is the 25th anniversary of the PDA/FDA conference and many of the presentations provided evidence of the significant progress made in research and medicine during this time.  It was fascinating to stand back for a few moments to see just how far we’ve come.  The overall conclusion I take from the two days of the conference that I attended are:

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EU vs. FDA: My Inspectors are More Rigorous Than Yours

by Barbara Unger, FDAzilla GMP Quality Expert

FDA and the EU have taken serious enforcement actions against several firms in the others geographic jurisdiction in calendar year 2016.  Perhaps this flurry of my-inspectors-are-more-rigorous-than-yours type represents an unofficial test of sorts as these two agencies move to rely more on each other’s inspections.   These inspections may test the limits and validity of the underlying assumption that would permit this mutual recognition.  Also interesting is that the European inspections specifically evaluate investigational product manufacture, something FDA does not generally do except on a for-cause basis.  Below we cover the three EU reports of GMP non-compliance issued regarding sites in the US and three FDA warning letters, one FDA import alert, and one untitled letter issued regarding sites in the EU.

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To Understand Data Integrity, Just Read These 6 FDA 483s

I asked Barb Unger a difficult question, “If you could just pick 6 483s to understand this Data Integrity problem, which 6 would you pick? And why?”  Here is her response.

From Barb:

As we continue to follow the data integrity story, let’s take a look at six (6) forms 483 associated with data integrity that had broad impact throughout the industry or resulted in serious enforcement actions including consent decree agreements. You will see that they are not limited to a single country and many of the observations are similar or exactly the same over a decade. Continue reading