← 483 OBSERVATION EXPLORER

FDA 483 OBSERVATION · #113 OF 1,000 MOST-CITED

Lack of or inadequate receiving acceptance procedures

FDA cited this observation 202 times across 189 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
Devices202
BY FISCAL YEAR
FY20267
FY202520
FY202415
FY202324
FY202216
FY202110
FY202017
FY201936
FY201832
FY201725

How FDA worded it — real examples

Procedures for acceptance of incoming product have not been adequately established.

My Medical Store LLC · Fort Lauderdale, Florida · Devices · 2025-12-18

Procedures for acceptance of incoming product have not been adequately established.

Mercury Enterprises, Inc. · Clearwater, Florida · Devices · 2025-12-11

Procedures for acceptance of incoming product have not been adequately established.

Specialty Health Products CO, LLC · Phoenix, Arizona · Devices · 2025-12-11

Procedures for acceptance of incoming product have not been adequately established.

3D Diagnostix Inc. · Allston, Massachusetts · Devices · 2025-11-21

Procedures for acceptance of incoming product have not been adequately established.

IRAY IMAGING LLC · Solon, Ohio · Devices · 2025-10-24

Procedures for acceptance of incoming product have not been adequately established.

Medaesthetics International, LLC · Phoenix, Arizona · Devices · 2025-10-22

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.

Pharmaceutical quality systemMedical 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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