Company
United StatesAED Battery Exchange LLC, Wauconda, IL – FDA Inspections
Inspection records and compliance data for AED Battery Exchange LLC in Wauconda, Illinois. 4 FDA inspections on record, 1 Form 483, last inspected April 09, 2026.
Company Profile
This profile covers AED Battery Exchange LLC based in Wauconda, Illinois, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected February 12, 2013. Last inspected April 9, 2026.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Design verification - documentation1 inspection
- Document review, approval by designated individual1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 9, 2026 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1312226 |
| November 8, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1157059 |
| June 26, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1015540 |
| February 12, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 818386 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
AED Battery Exchange LLC
FEI Number
3009886119
Address
1000 Brown St Ste 206, Wauconda, Illinois 60084, United States
Country
United States
ID: 12b427c9-efc4-4ba6-8f82-0247f692ac17