20 New FDA 483s Added | October 15th 2018

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 […]

Week of September 30th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

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 […]

7 New Recalls | Week of September 30th 2018

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 […]

31 New FDA 483s Added | October 8th 2018

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 […]

Week of September 23rd 2018 | FDA Sent These Warning Letters to Pharma Companies

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 […]

Just Issued Recalls, 483s, Laws, & Warning Letters | September 2018

Enforcement: Recalls:Some Class II and III recallsThe effects of the valsartan API problems continue — see the 2 News Scan Top Stories.Import Alerts:A few import alerts including 1 valsartan site. I would look for a warning letter for this site soon. This same site also received a report of GMP non-compliance from the EDQM and EMA. […]

What’s the Big Deal with Form FDA 483s?

Today, we cover the basics. Some of you pros out there know this stuff all too well… What is a Form FDA 483? The FDA has authority to inspect factories that manufacture products regulated by the FDA. FDA inspectors can come in and inspect any given facility at any time, and they essentially write down […]

36 New FDA 483s Added | October 1st 2018

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=22] Like this & want more? Sign up to get […]

Week of September 16th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

FDA published a total of 12 warning letters this week including: 2 to compounding pharmacies1 to an API manufacturer2 to finished drug manufacturers1 to a device manufacturer DEVICES: ITG-Medev Inc (San Francisco, CA) received a warning letter on September 7th, 2018 based on the outcome of an inspection ending June 6th, 2018. The firm manufactures […]

Posted FDA 483 Violations | Week of 9/16/18

It’s 483 study time, and our GMP expert has extracted the key points in this week’s featured 483 posted by the FDA. Violations ranged from failing to provide scientific reasons for invalidating OOS results to failing to prevent colored residues on equipment. DRUGS: Zhejiang Huahai Pharmaceutical Co. Ltd received an 11-page 483 at the close of […]
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