Statements (51)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory process
|
| gptkbp:appliesTo |
pharmaceutical manufacturers
medical device manufacturers food manufacturers biologics manufacturers tobacco product manufacturers |
| gptkbp:authority |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:canBe |
follow-up inspection
for-cause inspection pre-approval inspection routine inspection |
| gptkbp:cause |
gptkb:Form_483
product recall regulatory action Import Alert Warning Letter |
| gptkbp:conductedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:documentation |
gptkb:Establishment_Inspection_Report
|
| gptkbp:frequency |
risk-based
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA inspection
|
| gptkbp:includes |
facility walkthrough
interviews with staff review of records sampling and testing |
| gptkbp:purpose |
ensure compliance with regulations
|
| gptkbp:scope |
gptkb:CAPA_(Corrective_and_Preventive_Actions)
adverse event reporting record keeping risk management environmental monitoring data integrity product testing employee training equipment maintenance product labeling sanitation and hygiene change control complaint handling recall procedures Good Clinical Practice compliance Good Laboratory Practice compliance Good Manufacturing Practice compliance batch release distribution records quality systems sterility assurance supplier qualification supply chain controls validation activities |
| gptkbp:bfsParent |
gptkb:COVID-19_vaccine_manufacturing_contamination_(2021)
|
| gptkbp:bfsLayer |
6
|