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483sOnline.com is your own personal pre-investigation intelligence tool that identifies exactly what investigators are focusing on before they show up.

483sOnline.com is more than just a library of 3,100 Form 483s.  It’s a tool you can use every day to help stay in compliance with FDA regulations. You can search:

  • By keyword or phrase: Search through all observations for each 483 — by the exact keyword or phrase you’re looking for, giving you the intelligence you need;
  • By date: Find out what issues the investigators have focused on in the recent past;

  • By company: Find out how things are going at companies just like yours;
     
  • By investigator name: Learn about the investigating trends of the official that’s likely to conduct your next inspection.

For example, a search of drug companies in the Central region with observations related to quality control in 2013 will return six results, including:

Grand River Aseptic Manufacturing, Inc.
Issue Date
Aug 28, 2013
Category
Drug
Region
Central
Inspector(s): Rebecca E. Dombrowski

Click here for a free download of the Grand River Form 483 seen above.

For example, a search of device companies in the Central region with observations related to design control in 2013 will return four results, including:

Automated Ophthalmics, Inc.
Issue Date
Mar 19, 2013
Category
Device
Region
Central
Inspector(s): Holly S. Simms

Click here for a free download of the Automated Opthalmics Form 483 seen above.

Unlike other services our database is updated weekly — our staff continuously monitor all FDA investigator activity and requests all corresponding 483s. 

Each week we’ll send you an email telling you which 483s have been added.

 

This subscription offer is for one user only, but you're eligible for a significant discount on a multi-user and/or multi-location license. Get your entire company or department involved in scouring 483s for information that can help you with FDA inspections. For more information, contact us at (888) 838-5578.