FDA inspectional observation form
GPTKB entity
Statements (22)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
manual
|
| gptkbp:alsoKnownAs |
gptkb:Form_FDA_483
|
| gptkbp:cause |
further regulatory action
|
| gptkbp:compatibleWith |
a comprehensive compliance report
a list of all possible violations final agency determination of violation |
| gptkbp:contains |
list of inspectional observations
|
| gptkbp:documentation |
potential violations of FDA regulations
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA inspectional observation form
|
| gptkbp:issuedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:providesFor |
management of inspected facility
|
| gptkbp:purpose |
to document observations made during FDA inspections
|
| gptkbp:responseRequired |
written response from inspected entity
|
| gptkbp:responseTimeframe |
15 business days
|
| gptkbp:usedFor |
medical device inspections
food facility inspections biologics inspections pharmaceutical inspections tobacco inspections |
| gptkbp:usedIn |
FDA inspections
|
| gptkbp:bfsParent |
gptkb:Form_483
|
| gptkbp:bfsLayer |
8
|