← 483 OBSERVATION EXPLORER

FDA 483 OBSERVATION · #902 OF 1,000 MOST-CITED

Cleaning SOPs/schedules

FDA cited this observation 20 times across 18 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
Drugs20
BY FISCAL YEAR
FY20252
FY20241
FY20221
FY20211
FY20201
FY20195
FY20187
FY20172

How FDA worded it — real examples

Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.

The Original Bradford Soap Works, Inc. · West Warwick, Rhode Island · Drugs · 2025-05-27

Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.

Pharmco Laboratories Inc. · Titusville, Florida · Drugs · 2025-03-20

Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.

Nissui Corporation · Tsukuba · Drugs · 2023-12-15

Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.

Cipla Limited · Salcette · Drugs · 2022-08-26

Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.

Pharmco Laboratories Inc. · Titusville, Florida · Drugs · 2021-09-22

Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.

Dendreon Pharmaceuticals LLC · Seal Beach, California · Drugs · 2019-11-08

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 validationPharma industry

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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