Investigations have historically been among the most commonly cited observations in FDA 483s so a robust investigation strategy is an important element of any firm’s quality program. A strong investigation is supported by a thorough and complete evaluation of the major elements: root cause analysis, impact assessment and scope, historical analysis, establishment of CAPAs, and a […]
This morning, I went into the Federal Register pre-publication page and noticed there were no postings from the FDA. While this usually happens maybe two or three times a month, I also noted that there were no new postings on the What’s New page on the FDA website. Then I saw that MSN posted an […]
I remember when I was at the FDA and presenting at a meeting discussing a guidance that industry had been waiting for the FDA to publish for a year or so. I noted that it would be released soon! Immediately someone from the audience asked, “what’s the FDA’s definition of soon?” I thought for a […]
Some common FDA 483 citations pertaining to cleaning validation are regarding consistency in monitoring of cleaning and the complete documentation of cleaning. It is critical to implement a robust monitoring process that is supported by detailed documentation. Ensuring that the SOPs for all aspects of cleaning are clear, detailed, and contain illustrations (where appropriate) to ensure […]
For those of you that have been following the saga of the attack on the skinny label, we may be getting close to a solution. Remember that a skinny label is labeling that cuts out a particular use or information protected by patent or market exclusivity of the branded product. This allows for a generic […]
In the latest CDER Science Spotlights, available (here), the FDA provides some insight into the development of the Carcinogenic Potency Categorization Approach (CPCA) to determine recommended acceptable intake limits of N-nitrosamine impurities in drug products. The latest revision of the Nitrosamine Impurity guidance updated in September 2024 (here) provided better integration of the overall assessment […]
The pharmaceutical industry is entering a transformative era with the Food and Drug Administration’s (FDA) newly established pathway for nonprescription drug products with an Additional Condition for Nonprescription Use (ACNU), with the final rule announced in a December 2024 Federal Register Notice (here). This new rule aims to broaden consumer access to safe and effective […]
The logbook is the original audit trail mechanism as predicated in Eudralex, Volume 4, Chapter 4, Section 4.31. Is it too simple to automate or are we addicted to the simplicity of using them? Regardless, the industry struggles to automate the review of one of the simplest controls. In 2024, there were twenty-nine inspectional FDA 483s due to the […]
According to Fraiser Kansteiner’s article published on January 2, 2025 in Fierce Pharma (here), “Lilly on Wednesday filed a motion to intervene in a lawsuit brought by compounding industry group the Outsourcing Facilities Association (OFA) and compounder FarmaKeio Custom Compounding in U.S. District Court in Fort Worth, Texas.” As so the saga goes on. Lilly is […]
Just to add a little bit of folly, we have a short holiday poem for you to ponder! Due to the current uncertainty in the industry and the future leadership and priorities of the FDA, I’ve taken a somber tone in this season’s message. Maybe next year we can add some humor back into the […]
