FDA 483 OBSERVATION · #1021 OF 1,932 MOST-CITED
Arm preparation
FDA cited this observation 17 times across 16 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
The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood.
The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood.
The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood.
The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood.
The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood.
The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood.
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 →