FDA 483 OBSERVATION · #1139 OF 1,932 MOST-CITED
Evaluation--microorganisms, damage
FDA cited this observation 14 times across 14 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
Incoming HCT/Ps were not evaluated for the presence and significance of microorganisms and not inspected for damage and contamination.
Incoming HCT/Ps were not evaluated for the presence and significance of microorganisms and not inspected for damage and contamination.
Incoming HCT/Ps were not evaluated for the presence and significance of microorganisms and not inspected for damage and contamination.
Incoming HCT/Ps were not evaluated for the presence and significance of microorganisms and not inspected for damage and contamination.
Incoming HCT/Ps were not inspected for damage and contamination.
Incoming HCT/Ps were not inspected for damage and contamination.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →