# OnCo record pharmaceutical-gmp-inspections (technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/technologies/pharmaceutical-gmp-inspections/>
  a schema:MedicalTherapy ;
  onco:kind "technology" ;
  schema:identifier "pharmaceutical-gmp-inspections" ;
  schema:name "GMP, inspections, Form 483s and warning letters"@en ;
  schema:description "Every cancer drug plant works under Good Manufacturing Practice rules and is inspected. When inspectors find problems they write them up (a Form 483 in the United States), and if the answers are poor a public warning letter, an import ban or a court order can follow. Those actions protect patients, and they are also how shortages begin."@en ;
  schema:url <https://onco.cc/technologies/pharmaceutical-gmp-inspections/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:citation <https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211>, <https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en>, <https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters>, <https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations>, <https://picscheme.org/> ;
  onco:status "standard-of-care" ;
  onco:tag "manufacturing-wave" ;
  onco:sections <https://onco.cc/fronts/drug-discovery/>, <https://onco.cc/fronts/chemotherapy/> ;
  onco:technologies <https://onco.cc/technologies/small-molecule-api-synthesis/>, <https://onco.cc/technologies/sterile-injectable-generics-manufacturing/>, <https://onco.cc/technologies/bcg-vaccine-manufacturing/>, <https://onco.cc/technologies/monoclonal-antibody-manufacturing/>, <https://onco.cc/technologies/cell-therapy-release-testing/>, <https://onco.cc/technologies/radiopharmaceutical-gmp-release/>, <https://onco.cc/technologies/generic-drug-shortage-response/> ;
  onco:companies <https://onco.cc/companies/intas/>, <https://onco.cc/companies/lonza/>, <https://onco.cc/companies/samsung-biologics/>, <https://onco.cc/companies/wuxi-biologics/>, <https://onco.cc/companies/catalent/>, <https://onco.cc/companies/novartis/>, <https://onco.cc/companies/pfizer/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-regulatory-fragmentation/>, <https://onco.cc/bottlenecks/b-drug-pricing/> .