Company
United StatesEvenflo Co Inc, Miamisburg, OH – FDA Inspections
Inspection records and compliance data for Evenflo Co Inc in Miamisburg, Ohio. 3 FDA inspections on record (1 OAI), last inspected January 17, 2013.
Company Profile
This profile covers Evenflo Co Inc based in Miamisburg, Ohio, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 0
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected February 2, 2009. Last inspected January 17, 2013.
Most cited issue areas
- Design transfer - Lack of or inadequate procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 17, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 814561 |
| March 4, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 651447 |
| February 2, 2009 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 565407 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Evenflo Co Inc
FEI Number
3001329238
Address
225 Byers Rd, Miamisburg, Ohio 45342, United States
Country
United States
ID: 201fff6c-a4f4-407f-8732-fe15d53dfb9f