Category Archives: FDAzilla

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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October: FDA cGMP Quality News Briefing

What industry news have you been reading this month? At FDAzilla, we’ve compiled the most noteworthy articles we’ve come across in the weeks since our last update. This month’s picks include information from two conferences, surprising warning letters abroad and in the US, an explanation QSIT protocol, and stories of both exemplary and reprehensible strategies from companies dealing with in-house deficiencies. Take a look:

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Interval Between Inspection and Warning Letters Starts to Decrease

Interval Between Inspection and Warning Letters Starts to Decrease

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

 

A blog entry that evaluated FDA enforcement actions in the first half of FY2016 provided data to demonstrate that the interval between GMP drug inspections and warning letters almost doubled since FY2013.  The relevant table and graph is provided below.

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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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Sterility Assurance and Cross Contamination

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

Forms 483 Addressing Sterility Assurance and Cross-Contamination 

Along with data integrity, deficiencies in sterility assurance and the potential for product or API contamination identified during FDA inspections often lead to warning letters. Also many product recalls are based on lack of sterility assurance or less frequently on potential cross contamination.  Here we take a look at six forms 483 that include observations associated with sterility assurance and potential cross contamination.  These are certainly not meant to provide an all-inclusive view of the topic, but rather represent recent inspection observations in these areas to demonstrate the broad scope of the topic.  FDA’s flurry of inspections and enforcement actions against compounding pharmacies and outsourcing facilities focuses heavily of requirements associated with expectations regarding aseptic manufacture of sterile drug products. These sites are often also cited for the potential for cross contamination. Lack of sterility assurance and the potential for cross contamination, particularly by high potency compounds or sensitizing agents both have potentially serious consequences for patient safety.   Many compounding pharmacies and outsourcing facilities have recalled large numbers of products due to concerns about sterility assurance.  We include one example of this type of facility in the collection presented below.  Failure to complete adequate cleaning validation for multi-product equipment is often another source of potential cross contamination even when products do not include high potency compounds or sensitizing agents.

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Haven’t visited us for a while? Get up to speed in 4 minutes

If you haven’t been to FDAzilla.com in a while, then you’ve come to the right place. If any part of your job involves preparing your company for FDA GMP inspections, let me take you on a quick tour of some tools and resources that you might find useful!  Take 4 minutes and check out these 4 things:

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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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Check out the new Enforcement Analytics video

If part of your job involves preparing for inspections or analyzing FDA cGMP inspection trends, you should watch this video:

 


Any questions? Want to get a live demo for you or your team? Contact Ben Anderson at ben@FDAzilla.com.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence.