Category Archives: FDA

The FDA Re-Org Has Begun. What Does it Mean for You?

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

BACKGROUND:

The FDA began a plan to align the Office of Regulatory Affairs (ORA) into a ‘program based structure’ in 2013.  This reorganization is now being implemented. The ORA is the lead for all FDA field activities including inspections of regulated products and their manufacturers, and review of imported products.  Effective May 15, 2017, we enter the transition phase as the FDA moves to reorganize the ORA structure and function to align with the agency’s centers. The FDA provides information on each of the areas, including a ‘fact sheet’ and a ‘boundary map’ for these offices.

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When Will the FDA Move On from Data Integrity?

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 warehouse supervisor tearing out pages from your firm’s annual report and placing the pages into his pocket.”

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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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