← 483 OBSERVATION EXPLORER

FDA 483 OBSERVATION · #1424 OF 1,918 MOST-CITED

Notification of FDA of termination of investigator

FDA cited this observation 9 times across 8 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
Bioresearch Monitoring9
BY FISCAL YEAR
FY20261
FY20251
FY20241
FY20231
FY20201
FY20192
FY20171
FY20161

How FDA worded it — real examples

Failure to notify FDA of the ending, for cause, of an investigator's participation in an investigation.

Axsome Therapeutics, Inc. · New York, New York · Bioresearch Monitoring · 2026-02-06

Failure to notify FDA of the ending, for cause, of an investigator's participation in an investigation.

Milestone Pharmaceutiques Inc. · Saint-Laurent · Bioresearch Monitoring · 2024-11-19

Failure to notify FDA of the ending, for cause, of an investigator's participation in an investigation.

Vanda Pharmaceuticals Inc · Washington, District of Columbia · Bioresearch Monitoring · 2024-03-12

Failure to notify FDA of the ending, for cause, of an investigator's participation in an investigation.

Genentech, Inc. · South San Francisco, California · Bioresearch Monitoring · 2023-08-11

Failure to notify FDA of the ending, for cause, of an investigator's participation in an investigation.

Boehringer Ingelheim Pharmaceuticals, Inc. · Ridgefield, Connecticut · Bioresearch Monitoring · 2019-12-12

Failure to notify FDA of the ending, for cause, of an investigator's participation in an investigation.

Merck & Co. Inc · Rahway, New Jersey · Bioresearch Monitoring · 2019-09-06

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.

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