Remel Cleveland, a Division of Remel Inc. - Inspection Records
Inspection records and compliance data for Remel Cleveland, a Division of Remel Inc. in Oakwood Village, Ohio. 4 FDA inspections on record, 1 Form 483, last inspected February 03, 2025.
This profile covers Remel Cleveland, a Division of Remel Inc. based in Oakwood Village, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 16, 2010. Last inspected February 3, 2025.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 3, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1259798 |
| November 20, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1110500 |
| April 12, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1009751 |
| March 16, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 652081 |
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Name
Remel Cleveland, a Division of Remel Inc.
FEI Number
1000515493
Address
1 Thermo Fisher Way, Oakwood Village, Ohio 44146, United States
Country
United States
ID: 021debca-74ec-4d32-b2e1-1766d4b852d2