Company
United StatesOpen Implants, LLC, Woburn, MA – FDA Inspections
Inspection records and compliance data for Open Implants, LLC in Woburn, Massachusetts. 2 FDA inspections on record, 1 Form 483, last inspected August 04, 2021.
Company Profile
This profile covers Open Implants, LLC based in Woburn, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 29, 2019. Last inspected August 4, 2021.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 4, 2021 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1148479 |
| May 29, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1091014 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Open Implants, LLC
FEI Number
3012991306
Address
800 W Cummings Park Ste 4900, Woburn, Massachusetts 01801, United States
Country
United States
ID: 30951078-1c40-462b-a5ef-cce61712af7d