FDA Inspection 1015540 — AED Battery Exchange LLC
The FDA completed an inspection of AED Battery Exchange LLC on Jun 26, 2017 in Wauconda, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 26, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wauconda, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |