Company
United StatesR4 LLC, Strongsville, OH – FDA Inspections
Inspection records and compliance data for R4 LLC in Strongsville, Ohio. 2 FDA inspections on record (1 OAI), last inspected September 20, 2010.
Company Profile
This profile covers R4 LLC based in Strongsville, Ohio, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected March 23, 2009. Last inspected September 20, 2010.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Document review, approval documentation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 20, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 682103 |
| March 23, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 568916 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
R4 LLC
FEI Number
3006790946
Address
17999 Foltz Pkwy, Strongsville, Ohio 44149, United States
Country
United States
ID: fc027964-cc1b-4772-9a20-d0a55c34a54d