Resources

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. […]

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 […]

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 […]

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 […]

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 […]

We took a snapshot of the 2 warning letters the FDA sent to food companies last month. Food violations ranged from illegally selling an animal for slaughter to selling new “drugs” without FDA approval. From companies in Nebraska and Wisconsin, here they are: Dolezal Dairy,Pender, NE – violations include:Offering for sale an animal for slaughter […]

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=21] Like this & want more? Sign up to […]

FDA posted 7 warning letters this week including: 2 warning letters to Medtronic regarding non-conformance that resulted in Class I recall of a defibrillator earlier in 20181 firm in Canada1 firm in China Also, this week the “U.S. Food and Drug Administration today announced a series of critical and historic enforcement actions related to the […]

1. Select an ePRO provider who can support the Primary Investigator’s access to source data. To help you choose a provider, ask: What happens to your subjects’ diary data?Does it disappear from the device, evaporating into the cloud hosted by your ePRO provider?Is your provider’s solution to print “copies” of the device data at the […]

In the past 2 weeks, 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=20] Like this & want more? Sign up to […]