Company
United StatesM.E.E.I. Boston Keratoprosthesis, Boston, MA – FDA Inspections
Inspection records and compliance data for M.E.E.I. Boston Keratoprosthesis in Boston, Massachusetts. 3 FDA inspections on record, last inspected July 25, 2017.
Company Profile
This profile covers M.E.E.I. Boston Keratoprosthesis based in Boston, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected September 23, 2009. Last inspected July 25, 2017.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 25, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1024977 |
| November 20, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 808126 |
| September 23, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 613689 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
M.E.E.I. Boston Keratoprosthesis
FEI Number
1000120597
Address
243 Charles St Fl 5, Boston, Massachusetts 02114, United States
Country
United States
ID: 4c0de3d3-23da-4b9e-96f9-6c4632010fae