Category Archives: quality assurance

Warning Letters 2016 – Data Governance & Data Integrity

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

In 2015 we published a collection of FDA GMP warning letters that included deficiencies in data governance and data integrity.  Here we provide the same information for 2016 drug GMP warning letters. These should serve as a resource for GMP audit staff and QA staff as they evaluate their own firms and contract sites for gaps in these areas.  In this introduction, we provide tables and graphs identifying the dates of the warning letters, firms to which they were issued, and the country where the facility is located.  We also provide a table that shows the trends over time for location of countries where facilities receiving these warning letters were located, beginning in 2008.  And, finally, we provide a tabulation of the regulations most frequently cited for these deficiencies in 2015 and 2016.

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FDA Sent These 8 Warning Letters for Pharma Companies | March 2017

We took a snapshot of the 8 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to monitor the water purification system to personnel not wearing appropriate clothing to prevent contamination.

From pharmaceuticals in California, Singapore, and more, here they are:
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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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Assessing Your Readiness State for FSMA: Stabilize, Then Benchmark

Assessing Your Readiness State for FSMA: Stabilize, Then Benchmark

I find that the FSMA readiness of major food brands and CPGs runs the gamut from “scrambling” to “got it covered” — and everywhere in between. Smaller companies have been given more time to prepare by the FDA. Larger companies have considerably less runway to get ready.

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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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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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