FDA 483 OBSERVATION · #914 OF 1,932 MOST-CITED
Connections easily cleanable, located and protected
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.
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.
How FDA worded it — real examples
Filling connections not located and protected so as to minimize the hazard of contamination of the water supply.
Filling connections not located and protected so as to minimize the hazard of contamination of the water supply.
Filling connections not located and protected so as to minimize the hazard of contamination of the water supply.
Filling connections not located and protected so as to minimize the hazard of contamination of the water supply.
Filling connections not easily cleanable so as to minimize the hazard of contamination of the water supply.
Filling connections not located and protected so as to minimize the hazard of contamination of the water supply.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →