Recent 483s In The News Posts

THE BASICS In January 2024, the FDA issued a deeply concerning Form 483 to Jiangsu Hengrui Pharmaceuticals, a China-based manufacturer, during an inspection classified as Official Action Indicated (OAI). The inspection revealed eight primary observations, with six of these graded as Critical by Redica Systems’ Quality System Risk Models. When...

THE BASICS This is resulting from an inspection of the facility on South Delaware Street, Indianapolis, FEI #1819470, which began on September 11, 2023. FDA personnel spent five (5) days on-site. The 483 document is available for purchase/download here. The 483 contains five observations, ranging from failure to ensure prescribing HCPs...

THE BASICS This is resulting from an inspection of the facility at One Moderna Way, Norwood, MA, FEI #3014937058, which began on September 11, 2023. FDA personnel spent nine (9) days on-site. The 483 document is available for purchase/download here. The 483 contains five observations, ranging from failure to properly...

Resources to Avoid & Respond to FDA 483s

Form FDA 483s. If you’re part of the very small fraternity of people who have “FDA 483s” in your vocabulary, this website is for you. Please see our list of most helpful resources all about FDA 483 Letters.

We welcome you to add to this list by submitting your links here. We’ll credit you as the source, if you’d like, or keep your contribution anonymous. The goal is to bring more transparency and mutual sharing/learning on Form FDA 483s so that you can work smarter with the FDA.

FDA 483s 101

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