FDA 483 OBSERVATION · #1162 OF 1,932 MOST-CITED

Clean & orderly

FDA cited this observation 13 times across 12 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
Biologics13
BY FISCAL YEAR
FY20262
FY20251
FY20243
FY20231
FY20201
FY20192
FY20172
FY20161

How FDA worded it — real examples

Failure to maintain facilities in a clean and orderly manner.

The American National Red Cross · Worcester, Massachusetts · Biologics · 2026-04-08

Failure to maintain facilities in a clean and orderly manner.

Olgam Life LLC · Jamaica, New York · Biologics · 2026-01-22

Failure to maintain facilities in a clean and orderly manner.

Vitalant · Denver, Colorado · Biologics · 2025-02-07

Failure to maintain facilities in a clean and orderly manner.

Carter BloodCare - Texoma · Sherman, Texas · Biologics · 2024-08-23

Failure to maintain facilities in a clean and orderly manner.

CSL Plasma Inc. · Saginaw, Michigan · Biologics · 2024-07-12

Failure to maintain facilities in a clean and orderly manner.

Continental Services Group, Inc. · Miami, Florida · Biologics · 2024-05-21

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.

Biologics industry →

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