Nanoentek America, Inc
220 Bear Hill Road Suite 102, North Waltham, MA, US
Registered product codes
6 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 3007113174.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Mar 1, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Mar 1, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗21 CFR 820.20(c)Management review - Lack of or inadequate procedures
121 CFR 820.22Quality audits - Lack of or inadequate procedures
121 CFR 820.100(a)Lack of or inadequate procedures
121 CFR 820.150Lack of or inadequate procedures for storage.
121 CFR 820.198(a)Lack of or inadequate complaint procedures
1
- 21 CFR 820.20(c)Mar 1, 2024
Management review - Lack of or inadequate procedures
- 21 CFR 820.22Mar 1, 2024
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.100(a)Mar 1, 2024
Lack of or inadequate procedures
- 21 CFR 820.150Mar 1, 2024
Lack of or inadequate procedures for storage.
- 21 CFR 820.198(a)Mar 1, 2024
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.