Resources

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 […]

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=26] Like this & want more? Sign up to get […]

The FDA posted 13 warning letters this week including: A collection from the Center for Tobacco Products1 to a PET firm1 to a device firm1 to a compounding pharmacy DEVICES: Datascope Corporation (Fairfield, NJ) received a warning letter on September 11th, 2018 based on the outcome of an inspection ending June 11th, 2018. The firm […]

From microbial contamination to a pharmacist reporting blue specks on tablets where there should be none, here are last week’s recalls: Keep the recalls away from your products. Get your free GMP wisdom. DRUG RECALLS: [supsystic-tables id=24] UNCLASSIFIED RECALLS: [supsystic-tables id=25] Like this & want more? Sign up to get free weekly content […]

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=23] Like this & want more? Sign up to get […]

FDA posted 6 warning letters on the website this week including: 1 letter issued to a compounding pharmacy1 issued to a finished drug facility DRUGS: Wilson Medicine Company (India) received a warning letter on September 11th 2018 based on the outcome of an inspection ending March 1st 2018. The firm manufactures OTC drugs. FDA suggests […]