FDA 483 OBSERVATION · #1371 OF 1,932 MOST-CITED

Cleaning, disinfecting, flushing

FDA cited this observation 10 times across 9 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
Parts 1240 and 125010
BY FISCAL YEAR
FY20261
FY20255
FY20221
FY20181
FY20171
FY20161

How FDA worded it — real examples

Failure to clean, disinfect and flush a potable water system when required by FDA to prevent the introduction, transmission, or spread of communicable diseases.

Circle Line Sightseeing Yachts Inc · New York, New York · Parts 1240 and 1250 · 2026-06-29

Failure to a potable water system when required by FDA to prevent the introduction, transmission, or spread of communicable diseases.

HornBlower Cruises and Events LLC · New York, New York · Parts 1240 and 1250 · 2025-09-30

Failure to clean and disinfect a potable water system when required by FDA to prevent the introduction, transmission, or spread of communicable diseases.

American Cruise Lines Inc dba American Heritage · Guilford, Connecticut · Parts 1240 and 1250 · 2025-09-29

Failure to clean, disinfect and flush a potable water system when required by FDA to prevent the introduction, transmission, or spread of communicable diseases.

HornBlower Cruises and Events LLC · New York, New York · Parts 1240 and 1250 · 2025-07-31

Failure to clean and disinfect a potable water system when required by FDA to prevent the introduction, transmission, or spread of communicable diseases.

Allegiant Air · New Windsor, New York · Parts 1240 and 1250 · 2025-04-22

Failure to clean and disinfect a potable water system when required by FDA to prevent the introduction, transmission, or spread of communicable diseases.

Interlaken Capital Aviation Services · White Plains, New York · Parts 1240 and 1250 · 2025-01-28

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.

Cleaning validation →

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