Akervall Technologies
1512 Woodland Dr, Saline, MI, US
Registered product codes
5 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 3011547262.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Nov 6, 2025
Compliance: Devices · Citations posted
Inspection citations
10 on file
Top cited requirements
Compare to industry ↗21 CFR 803.17Lack of Written MDR Procedures
121 CFR 820.22Quality audits - Lack of or inadequate procedures
121 CFR 820.25(b)Training - Lack of or inadequate procedures
121 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
1
- 21 CFR 803.17Nov 6, 2025
Lack of Written MDR Procedures
- 21 CFR 820.22Nov 6, 2025
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Nov 6, 2025
Training - Lack of or inadequate procedures
- 21 CFR 820.30(i)Nov 6, 2025
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Nov 6, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(g)Nov 6, 2025
Equipment Installation, Placement, Specified Requirements
- 21 CFR 820.72(a)Nov 6, 2025
Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.80(c)Nov 6, 2025
Documentation
- 21 CFR 820.90(a)Nov 6, 2025
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.198(a)Nov 6, 2025
Lack of or inadequate complaint procedures
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.