FDA 483 OBSERVATION · #1455 OF 1,918 MOST-CITED
Clean hands
FDA cited this observation 8 times across 8 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
Persons with unclean hands were engaged in handling food and equipment.
Persons with unclean hands were engaged in handling food, drink, utensils and equipment.
Persons with unclean hands were engaged in handling food.
Persons with unclean hands were engaged in handling drink, utensils and equipment.
Persons with unclean hands were engaged in handling food.
Persons with unclean hands were engaged in handling food.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →