Company
United StatesNortheast Scientific Inc., Waterbury, CT – FDA Inspections
Inspection records and compliance data for Northeast Scientific Inc. in Waterbury, Connecticut. 4 FDA inspections on record, 1 Form 483, last inspected July 26, 2022.
Company Profile
This profile covers Northeast Scientific Inc. based in Waterbury, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 8, 2012. Last inspected July 26, 2022.
Most cited issue areas
- Design plans - Lack of or inadequate1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 26, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1177884 |
| February 23, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1042605 |
| May 7, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 878627 |
| March 8, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 774237 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Northeast Scientific Inc.
FEI Number
3005467144
Address
2142 Thomaston Ave, Waterbury, Connecticut 06704, United States
Country
United States
ID: cb675184-8c36-44ea-8a5a-7917071f1e89