Company
United StatesTeratech Corporation, Burlington, MA – FDA Inspections
Inspection records and compliance data for Teratech Corporation in Burlington, Massachusetts. 3 FDA inspections on record, 1 Form 483, last inspected April 12, 2018.
Company Profile
This profile covers Teratech Corporation based in Burlington, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 5, 2011. Last inspected April 12, 2018.
Most cited issue areas
- Design verification - Lack of or inadequate procedures1 inspection
- Lack of or inadequate procedures for storage.1 inspection
- Lack of System for Event Evaluations1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 12, 2018 | Not classified | Medical Devices & Rad Health | 1081691 |
| August 28, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 851968 |
| August 5, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 740576 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Teratech Corporation
FEI Number
3002315840
Address
77-79 Terrace Hall Ave, Burlington, Massachusetts 01803, United States
Country
United States
ID: efab230d-e183-4dff-a196-1dad8589d9fa