FDA 483 OBSERVATION · #1282 OF 1,932 MOST-CITED
Establishing a system
FDA cited this observation 11 times across 11 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
A tracking system that enables the tracking of HCT/Ps back and forth from the donor to the consignee or final disposition was not maintained and followed.
A tracking system that enables the tracking of HCT/Ps back and forth from the donor to the consignee or final disposition was not established.
A tracking system that enables the tracking of HCT/Ps back and forth from the donor to the consignee or final disposition was not established, maintained and implemented.
A tracking system that enables the tracking of HCT/Ps back and forth from the donor to the consignee or final disposition was not followed.
A tracking system that enables the tracking of HCT/Ps back and forth from the donor to the consignee or final disposition was not followed.
A tracking system that enables the tracking of HCT/Ps back and forth from the donor to the consignee or final disposition was not followed.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →