Analytical Control Systems
9058 Technology Drive, Fishers, IN, US
Registered product codes
3 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 1825740.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Mar 30, 2026
Compliance: Devices · Citations posted
Inspection citations
8 on file
Top cited requirements
Compare to industry ↗ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
1ISO 13485:2016 Clause 5.6.1Management review procedures not documented
1ISO 13485:2016 Clause 6.3Requirements for infrastructure not documented
1ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
1ISO 13485:2016 Clause 7.5.6Procedures for validation of processes not documented
1ISO 13485:2016 Clause 8.2.2Lack of documented justification for not investigating complaint(s)
1
- ISO 13485:2016 Clause 4.1.2Mar 30, 2026
Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 5.6.1Mar 30, 2026
Management review procedures not documented
- ISO 13485:2016 Clause 6.3Mar 30, 2026
Requirements for infrastructure not documented
- ISO 13485:2016 Clause 7.1Mar 30, 2026
Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.5.6Mar 30, 2026
Procedures for validation of processes not documented
- ISO 13485:2016 Clause 8.2.2Mar 30, 2026
Lack of documented justification for not investigating complaint(s)
- ISO 13485:2016 Clause 8.2.4Mar 30, 2026
Internal audit procedures not documented
- ISO 13485:2016 Clause 8.5.2Mar 30, 2026
Corrective action procedures 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.