Category Archives: quality assurance

FDA Sent These 7 Warning Letters for Pharma Companies | April 2017

We took a snapshot of the 7 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from “products being misbranded” to sites “not ensuring that test procedures are scientifically sound.”

From pharmaceuticals in India, Pennsylvania, and more, here they are (starting with the most recent):
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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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2016 MHRA GMP Inspections yields 50% more deficiencies in key areas

MHRA Identified GMP Inspection Deficiencies,  2016

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

The MHRA published a large slide deck that addressed GMP deficiencies identified during inspections in 2016.  They published a slide deck of similar information for 2015 a few months ago.  In this blog, we look at some of the similarities and differences between the two years. The data only represent deficiencies noted for dosage forms and do not include those identified at inspections of API manufacturers.  We previously compared the FDA inspection observations for 2016 with the 2015 MHRA Deficiencies.  

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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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Inspect your FDA Inspector Before Your Inspection

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. Continue reading

The Story of 3 Consent Decrees

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 on the basis of a single form 483, or a single warning letter.  Generally, a series of events play out over time when critical inspection observations are not addressed and are identified in subsequent inspections.  Frequently one or more warning letters are involved.  Consent decree agreements often include fines, with the option for additional financial penalties if conditions to which the firm agrees are not met.  Often these firms are required to use a 3rd party consultants to perform lot release.  Firms operating under a consent decree agreement have largely lost their independence in GMP activities.  Unlike Corporate Integrity Agreement which have a defined duration, firms must petition to have the consent decree agreement condition rescinded.

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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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5 FEATURES TO LOOK FOR IN AN EIR

Benjamin Franklin said, “By failing to prepare, you are preparing to fail.”  Prepare for your FDA inspections with Establish Inspection Reports (EIR).  An EIR is the full report of an FDA inspection written by the investigators.  Among the features identified in the report are:

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Welcome to the new FDAzilla.com

Times are changing. We now live in a world where we have too much information and way too much raw data, but not enough wisdom.  More and more often, a lot of answers isn’t as useful as one good question. Isn’t the same true for our field of inspection preparation and regulatory intelligence. Why can’t we apply new data and word analysis technologies so that our teams can more effectively reach our quality goals? That’s where we’re headed at FDAzilla.  Continue reading