Hersill, S.l.
C/ PUERTO DE NAVACERRADA, 3, MOSTOLES (MADRID) Madrid (Province), ES
Registered product codes
8 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3007360714.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 10, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Apr 10, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
7 on file
Top cited requirements
Compare to industry ↗21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
121 CFR 820.25(b)Training - Lack of or inadequate procedures
121 CFR 820.30(a)Design control - no procedures
121 CFR 820.70(c)Environmental control Lack of or inadequate procedures
121 CFR 820.80(e)Documentation
121 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
1
- 21 CFR 803.17(a)(2)Apr 10, 2025
Lack of System for Determining MDR Events
- 21 CFR 820.25(b)Apr 10, 2025
Training - Lack of or inadequate procedures
- 21 CFR 820.30(a)Apr 10, 2025
Design control - no procedures
- 21 CFR 820.70(c)Apr 10, 2025
Environmental control Lack of or inadequate procedures
- 21 CFR 820.80(e)Apr 10, 2025
Documentation
- 21 CFR 820.90(a)Apr 10, 2025
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.184Apr 10, 2025
DHR - not or inadequately maintained
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.