← 483 OBSERVATION EXPLORER

FDA 483 OBSERVATION · #223 OF 1,000 MOST-CITED

Records of complaint investigation

FDA cited this observation 103 times across 100 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.

BY PROGRAM AREA
Devices103
BY FISCAL YEAR
FY20258
FY20246
FY202320
FY20223
FY20213
FY20208
FY201918
FY201818
FY201719

How FDA worded it — real examples

Records of complaint investigations do not include required information.

Metric Medical Devices Inc · Helotes, Texas · Devices · 2025-09-16

Records of complaint investigations do not include required information.

3D Medical Manufacturing, Inc. · Riviera Beach, Florida · Devices · 2025-08-15

Records of complaint investigations do not include required information.

Cognivue Inc. · Victor, New York · Devices · 2025-06-13

Records of complaint investigations do not include required information.

Directmed, Inc · Glen Cove, New York · Devices · 2025-05-15

Records of complaint investigations do not include required information.

Innovize LLC · Saint Paul, Minnesota · Devices · 2025-03-26

Records of complaint investigations do not include required information.

Harmonic Energetic Technologies Inc. · Liverpool, New York · Devices · 2025-03-07

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 managementMedical devices

Examples are a representative sample of FDA's published inspection observations. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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