Millstone Medical Testing - Ct, Llc
25 Village Hill Rd, Willington, CT, 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 1000120776.
FDA inspections
4 on file
- No Action Indicated (NAI)Jan 16, 2025
Compliance: Devices
- No Action Indicated (NAI)Jan 16, 2025
Postmarket Assurance: Devices
- Voluntary Action Indicated (VAI)Feb 15, 2024
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Feb 15, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
7 on file
Top cited requirements
Compare to industry ↗21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
121 CFR 820.70(c)Environmental control Lack of or inadequate procedures
121 CFR 820.75(c)Process changes - review, evaluation and revalidation
121 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
121 CFR 820.100(a)Lack of or inadequate procedures
1
- 21 CFR 820.50Feb 15, 2024
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Feb 15, 2024
Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(c)Feb 15, 2024
Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(c)Feb 15, 2024
Process changes - review, evaluation and revalidation
- 21 CFR 820.90(a)Feb 15, 2024
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Feb 15, 2024
Lack of or inadequate procedures
- 21 CFR 820.184Feb 15, 2024
DHR content
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.