Recently Posted FDA 483s
SKNV [Pompano Beach / United States of America]
Inspection End Date: March 6, 2025
HH FRESH TRADING CORP [Los Angeles / United States of America]
Inspection End Date: March 6, 2025
Saphena Medical, Inc. [West Bridgewater / United States of America]
Inspection End Date: March 4, 2025
PALMETTO ISOTOPES, LLC [Ridgeland / United States of America]
Inspection End Date: February 28, 2025
Eagle Pharmacy, Inc. [Hoover / United States of America]
Inspection End Date: February 27, 2025
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FDA483s.com is not an official FDA site. It simply provides information on recent 483s as well as tips on how to improve your compliance.
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
- FDA 483s (Wikipedia). The best 101 (and beyond) for understanding Form FDA 483s.
- FDA website ORA Reading Room. The FDA makes available Form FDA 483s that are “frequently requested”. Though these Form FDA 483s only make up a small percentage of all their Form FDA 483s, it is helpful to check this page often for updates (updated 1-2 times/month).
- FDA Inspections Guide YouTube Playlist (subscribe!)
- Who can see FDA 483s, and where do I get them? (Redica Systems Blog) Anyone can request 483s from the FDA through the Freedom of Information Act. But it usually takes longer than you might expect. Keep in mind that your request is in itself public information, so people can find out what you’re poking around for.
- FDA Post-Warning Letter Meetings are Not Agency Consultations (Redica Systems Blog)
- FDA Form 483: The Ultimate Guide (Redica Systems Blog)
- How to Respond to a Form FDA 483 (Redica Systems Blog). This is a complicated question and has many complicated answers. But the short answer is as specifically, comprehensively, quickly, and logically as possible for every single observation. Attack each one with passion. Explain to the FDA how the observations will be addressed, when, and how you’ll monitor it on an on-going basis. Don’t be that company that gets repeat violations.
Value-Added Tools
- Form FDA 483s Store. Redica Systems has thousands of FDA 483s, 483Rs, and EIRs that you can obtain instantly, anonymously, and economically. This is one of the only places where you can get access to this wide of a variety of 483s anywhere online, and it’s one of the largest collections available outside of the FDA.
- FDA Data Dashboard