FDA Inspection
AED Battery Exchange LLCAED Battery Exchange LLC – FDA Inspection, Jun 26, 2017
Record Details
This FDA Inspection record concerns AED Battery Exchange LLC, with an inspection on June 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b800d221-f2dc-4946-b935-45e7972bd44f
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1015540
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.40(a)Document review, approval by designated individual
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Other FDA inspections of AED Battery Exchange LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 9, 2026 | NAI | Compliance: Devices | |
| November 8, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 12, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for AED Battery Exchange LLC
- FDA Inspection 1312226 - 2026-04-09
- FDA Inspection 1157059 - 2021-11-08
- FDA Inspection 818386 - 2013-02-12
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