FDA 483 OBSERVATION · #1707 OF 1,918 MOST-CITED
Physical Assessment Determination - Skin Examination
FDA cited this observation 6 times across 6 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
Failure to determine that the donor was in good health based on an absence of punctures and scars indicative of injected drugs of abuse on the arms and forearms.
Failure to determine that the donor was in good health based on an absence of punctures and scars indicative of injected drugs of abuse on the arms and forearms.
Failure to determine that the donor was in good health based on an absence of punctures and scars indicative of injected drugs of abuse on the arms and forearms.
Failure to determine that the donor was in good health based on an absence of punctures and scars indicative of injected drugs of abuse on the arms and forearms.
Failure to determine that the donor was in good health based on an absence of punctures and scars indicative of injected drugs of abuse on the arms and forearms.
Failure to determine that the donor was in good health based on an absence of punctures and scars indicative of injected drugs of abuse on the arms and forearms.
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 →