Resources

Just a quick update – the FDAzilla Enforcement Analytics database was updated with data through April 25, 2017. We typically refresh the inspections data every 3 weeks or so, pair new warning letters with inspections every week, and add new 483s, EIRs, and 483 response letters every month. As of now, our database has: 703,956 […]

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): Vikshara Trading & Investments Ltd, Ahmedabad, […]

MHRA Identified GMP Inspection Deficiencies, 2016 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 […]

  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 […]

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: Badrivishal Chemicals & Pharmaceuticals, Maharashtra, India – 4 […]

We took a snapshot of the 7 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from failing to maintain complete data (again) to failing to produce suitable water. From pharmaceuticals in Japan, Illinois, and more, here they are (starting with the most recent): Megafine Pharma, Mumbai, India – 4 violations:Failure […]

What is the Future of Outsourcing Facilities? 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. According to the FDA website,FDA […]

The Real Story Behind Outsourcing Facilities: Are They Still Worth It and Were They Ever? 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 […]

We took a snapshot of the 10 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from products not meeting “the definition and standard for chocolate” to sites “refusing to permit the FDA inspection” altogether. From pharmaceuticals in Italy, Pennsylvania, and more, here they are (starting with the most recent): Berkeley […]

How to Prepare for a GMP Inspection for Small and Virtual Companies Preparing for GMP inspections, particularly pre-approval inspections, can be a challenge when resources are limited and staff may have little expertise in these important activities. This becomes especially complex for start-up companies that are virtual, or essentially virtual, and rely on contract manufacturers […]