Statements (32)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:FDA_inspectional_observation_form
|
| gptkbp:alsoKnownAs |
Inspectional Observations
|
| gptkbp:appliesTo |
pharmaceutical companies
medical device manufacturers food manufacturers biologics manufacturers tobacco product manufacturers animal drug manufacturers cosmetics manufacturers |
| gptkbp:cause |
Warning Letter
further regulatory action |
| gptkbp:compatibleWith |
final agency determination of compliance
|
| gptkbp:contentType |
observations of possible violations of the Food Drug and Cosmetic Act
|
| gptkbp:country |
gptkb:United_States
|
| gptkbp:dateOfFirstUse |
1970s
|
| gptkbp:followedBy |
company response
|
| gptkbp:format |
written document
|
| https://www.w3.org/2000/01/rdf-schema#label |
Form 483
|
| gptkbp:issuedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:language |
English
|
| gptkbp:legalBasis |
gptkb:21_CFR_Part_7
|
| gptkbp:openToPublic |
yes, via FOIA requests
|
| gptkbp:purpose |
communicate concerns discovered during FDA inspections
|
| gptkbp:recipient |
facility management
company management |
| gptkbp:responseRequired |
no, but response is strongly encouraged
|
| gptkbp:usedIn |
inspections of clinical investigators
inspections of contract research organizations inspections of laboratories inspections of manufacturing facilities |
| gptkbp:bfsParent |
gptkb:FDA_inspection
|
| gptkbp:bfsLayer |
7
|