FEI 1000138054
Sterigenics U.s., Llc
84 Park Rd, Queensbury, NY, US
MDR events2All time
Recalls0All time
Registered products288
Establishment typeSterilizeSterilize Medical Device for Another Party (Contract Sterilizer)
Registered product codes
288 product codes
Recent MDR events
2 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1000138054.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jun 24, 2026
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jun 24, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- ISO 13485:2016 Clause 7.1Jun 24, 2026
Product realization risk management processes not documented
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.