Resources

It’s violation study time, and our GMP expert has extracted the key documents from this week’s global headlines. To note is Operation Pangea XI as well as Europe’s multiple reports of GMP non-compliance. DRUGS: Cipla Limited received a 1-page, 2-observation 483 at the close of the inspection on September 28th 2018. Observations include:The commercial batch record […]

November is right around the corner, and FDAzilla is starting it off right. We will be at the ISPE Annual Conference in Philadelphia! This conference & expo will not disappoint: there is a world-class speaker roster that covers the FDA and the CDER office. What is particularly exciting for us at FDAzilla are the speakers […]

In the past week, we added the following 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Can’t find the 483 you’re looking for? Here’s a FREE company report instead. [supsystic-tables id=30] Like this & want more? Sign up to get […]

FDA posted 6 warning letters this week including: 1 issued to a pharmaceutical company in South Korea1 issued to a clinical trial investigator in California BIORESEARCH MONITORING: Ignatius P Godoy, M.D. (Paramount, CA) receive a warning letter based on the outcome of a BIMO inspection for a clinical study ending June 8th, 2018. The study […]

What does it even mean to officially respond to a 483 and, better yet, how can a 483 be avoided altogether? The answer is basically split into 3 parts: The Pre-ResponseThe Response ItselfThe Post-Response 1. The Pre-Response You can talk directly with the inspectors during and after the inspection to clarify points and understand their […]

Every day I work with companies that are looking to find innovative solutions that mitigate compliance risk. Befriend the Invisible FDA Inspector (sort of) To start, I asked the crowd if anyone had a CMO get inspected and receive a 483, but the CMO didn’t tell them. Many hands shot up, and it’s no surprise. […]

In the past week, we added the following 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Can’t find the 483 you’re looking for? Here’s a FREE company report instead. [supsystic-tables id=27] Like this & want more? Sign up to get […]

FDA posted 6 warning letters this week including: 1 to a device manufacturer1 for seafood HACCP1 for food preparation3 for tobacco DEVICE: Becton Dickinson Medical Systems (Franklin Kales, NJ) received a warning letter on September 14th, 2018 based on the outcome of an inspection that lasted from May 16th, 2018 through August 1st, 2018 (yes).When […]

We asked our GMP Editor in Chief 3 important questions and got 3 insightful answers. Using decades worth of professional experience, she shares both the strengths and weaknesses of this thing we call the 483. What are 1 or 2 key ways you’ve seen the FDA change over the last 10 years? I think the […]

From labels saying “you can take 4 pills” when it should really say “take 2” to injections with loose metal ferrules, here are last week’s recalls: An FDA update a day keeps the recalls away. Get free recall, 483, & Warning Letter reports. DRUG RECALLS: [supsystic-tables id=28] UNCLASSIFIED RECALLS: [supsystic-tables id=29] Like […]