Resources

BACKGROUND: The FDA began a plan to align the Office of Regulatory Affairs (ORA) into a ‘program based structure’ in 2013. This reorganization is now being implemented. The ORA is the lead for all FDA field activities including inspections of regulated products and their manufacturers, and review of imported products. Effective May 15, 2017, we enter the […]

We’ve all been following the health authority’s identified deficiencies in data governance and data integrity for the last few years, though this enforcement action has been ongoing for almost twenty years. A comprehensive GMP Intelligence program follows 483s and warning letters for information on the FDA’s focus. Particularly in this area, the best learning materials are often […]

Why Didn’t the Internal GMP Audit Group Identify that Before the Health Authorities? The FDA inspection observations continue to identify the shortcomings in many of the same areas over the last five or more years. That begs the question why. Does the FDA rapidly shift its focus in that short a time period? Are they applying […]

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 […]