FDA Inspection 840804 — Brooklands, Inc.
The FDA completed an inspection of Brooklands, Inc. on Jul 23, 2013 in Boca Raton, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jul 23, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Boca Raton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 537 | 21 CFR 820.70(a) | Production processes |