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): Continue reading →
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:
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.
We see a lot of people, all throughout the world, purchasing 483s from our FDA 483s store. For example, this month, customers from the United States, Germany, Albania, India, and China purchased 483s. As a reminder, here are 5 features to look for in a 483.
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): Continue reading →
We’ve compiled August and September’s most relevant, important news for anyone concerned with Pharmaceutical Industry GMP and FDA inspections. Our top 12 picks are listed chronologically by publication date. Happy reading!
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:
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.
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:
We see a lot of people, all throughout the world, purchasing 483s from our FDA 483s store. For example, this month, customers from Japan, Italy, China, United Kingdom, and the United States purchased 483s. As a reminder, here are 5 features to look for in a 483.
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.
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: