Company
United StatesIntact Medical Corporation, Framingham, MA – FDA Inspections
Inspection records and compliance data for Intact Medical Corporation in Framingham, Massachusetts. 2 FDA inspections on record, last inspected August 21, 2015.
Company Profile
This profile covers Intact Medical Corporation based in Framingham, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected April 4, 2012. Last inspected August 21, 2015.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- Investigation of device failures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 21, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 942382 |
| April 4, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 777532 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Intact Medical Corporation
FEI Number
3003405760
Address
550 Cochituate Rd Ste 25, Framingham, Massachusetts 01701, United States
Country
United States
ID: d325c991-0df9-45e3-82f4-1d2c2c69272b