FDA 483 OBSERVATION · #1144 OF 1,932 MOST-CITED

Failure to report

FDA cited this observation 13 times across 13 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.

What this grouping is not

An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.

BY PROGRAM AREA
Radiologic Health13
BY FISCAL YEAR
FY20241
FY20201
FY20191
FY20183
FY20173
FY20164

How FDA worded it — real examples

You did not immediately report to the Director, CDRH, FDA, an accidental radiation occurrence reported to or otherwise known to you. involving a product introduced or intended to be introduced into commerce by you.

Cogmedix, Inc. · West Boylston, Massachusetts · Radiologic Health · 2024-04-11

You did not immediately report to the Director, CDRH, FDA, an accidental radiation occurrence reported to or otherwise known to you. involving a product introduced or intended to be introduced into commerce by you.

Anodyne Therapy, LLC · Oldsmar, Florida · Radiologic Health · 2020-01-23

You did not immediately report to the Director, CDRH, FDA, an accidental radiation occurrence reported to or otherwise known to you. involving a product introduced or intended to be introduced into commerce by you.

Denterprise International, Inc. · Ormond Beach, Florida · Radiologic Health · 2019-05-06

You did not immediately report to the Director, CDRH, FDA, an accidental radiation occurrence reported to or otherwise known to you. involving a product introduced or intended to be introduced into commerce by you.

Nuvolase Inc. · Los Angeles, California · Radiologic Health · 2018-05-23

You did not immediately report to the Director, CDRH, FDA, an accidental radiation occurrence reported to or otherwise known to you. involving a product introduced or intended to be introduced into commerce by you.

FUJIFILM Healthcare Americas Corporation · Lexington, Massachusetts · Radiologic Health · 2018-03-29

You did not immediately report to the Director, CDRH, FDA, an accidental radiation occurrence reported to or otherwise known to you. involving a product introduced or intended to be introduced into commerce by you.

Medtronic Navigation, Inc.-Boxborough · Boxborough, Massachusetts · Radiologic Health · 2018-01-03

Related SPEQ references

Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.

Quality risk management →Medical devices →

Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →