FDA 483 OBSERVATION · #657 OF 1,932 MOST-CITED
Maintain and clean equipment
FDA cited this observation 34 times across 32 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.
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 0× the rate of the average FDA-cited firm (0.0% vs 7.8%), across 32 FEI-matched firms.
This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.
How FDA worded it — real examples
Failure to maintain equipment used in the collection, processing, compatibility testing, storage and distribution of blood and blood products.
Failure to maintain equipment used in the collection and storage of blood and blood products so as to facilitate cleaning and maintenance.
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.
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. Open the 483 observation explorer →