FDA 483 OBSERVATION · #734 OF 1,000 MOST-CITED
Maintain and clean equipment
FDA cited this observation 22 times across 22 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.
How FDA worded it — real examples
Failure to maintain equipment used in the collection of blood and blood products in a clean and orderly manner and so as to facilitate cleaning and maintenance.
Failure to maintain equipment used in the storage and distribution of blood and blood products.
Failure to maintain equipment used in the processing of blood and blood products in a clean and orderly manner.
Failure to maintain equipment used in the processing and compatibility testing of blood and blood products in a clean and orderly manner.
Failure to maintain equipment used in the storage of blood and blood products.
Failure to maintain equipment used in the collection, processing, storage and distribution of blood and blood products.
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.
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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