FDA Inspection 1001749 — Maclin Power Inc.
The FDA completed an inspection of Maclin Power Inc. on Dec 22, 2016 in Doral, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Dec 22, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3696 | 21 CFR 820.100(b) | Documentation |