FDA Inspection 837902 — Typhoon Water Wares Limited
The FDA completed an inspection of Typhoon Water Wares Limited on June 28, 2013 in Pocomoke City, MD. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 28, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pocomoke City, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3696 | 21 CFR 820.100(b) | Documentation |