Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
FDA form
|
| gptkbp:alsoKnownAs |
Inspectional Observations
|
| gptkbp:appliesTo |
pharmaceutical companies
medical device manufacturers food manufacturers biologics manufacturers cosmetics manufacturers |
| gptkbp:cause |
Warning Letter
further regulatory action |
| gptkbp:compatibleWith |
final agency determination
|
| https://www.w3.org/2000/01/rdf-schema#label |
Form FDA 483
|
| gptkbp:issuedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:issuedWhen |
inspection reveals potential violations
|
| gptkbp:legalBasis |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:notified |
management of objectionable conditions
|
| gptkbp:openToPublic |
yes
|
| gptkbp:presentedBy |
company management
|
| gptkbp:purpose |
document inspectional observations
|
| gptkbp:responseRequested |
company response
|
| gptkbp:responseTimeframe |
15 business days
|
| gptkbp:usedIn |
FDA inspections
|
| gptkbp:bfsParent |
gptkb:Establishment_Inspection_Report
|
| gptkbp:bfsLayer |
8
|