Company
United StatesOmarc Llc, Norwood, MA – FDA Inspections
Inspection records and compliance data for Omarc Llc in Norwood, Massachusetts. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected August 11, 2021.
Company Profile
This profile covers Omarc Llc based in Norwood, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 0
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected March 1, 2012. Last inspected August 11, 2021.
Most cited issue areas
- Design validation - documentation1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 11, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1150127 |
| October 28, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 991802 |
| August 24, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 796293 |
| March 1, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 769507 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Omarc Llc
FEI Number
3004036118
Address
588 Pleasant St Ste 2, Norwood, Massachusetts 02062, United States
Country
United States
ID: 2021bed7-6898-4a3b-b023-8d4e9a122a85