FDA 483 OBSERVATION · #1744 OF 1,918 MOST-CITED
Notify Consignees [Collecting Establishment]
FDA cited this observation 6 times across 3 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 notify consignees of the results of further testing for HCV within 45 calendar days after the donor tests reactive for evidence of HCV infection under the regulations.
Failure to notify consignees of the results of further testing for HIV within 45 calendar days after the donor tests reactive for evidence of HIV infection under the regulations.
Failure to notify consignees of the results of further testing for HIV within 45 calendar days after the donor tests reactive for evidence of HIV infection under the regulations.
Failure to notify consignees of the results of further testing for HCV and the results of the reactive screening test within 45 calendar days after the donor tests reactive for evidence of HCV infection under the regulations.
Failure to notify consignees to quarantine all previously collected in-date blood and blood components identified under the regulations (blood and blood components collected twelve months and less before the donor's most recent nonreactive screening tests or twelve months and less before the donor's reactive direct viral detection test) if intended for use for further manufacture into injectable products.
Failure to notify consignees of the results of the reactive screening test within 45 calendar days after the donor tests reactive for evidence of HCV infection under the regulations.
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 →