FDA Inspection 1066676 — Winfield Laboratories, Inc.
The FDA completed an inspection of Winfield Laboratories, Inc. on Sep 25, 2018 in Richardson, TX. 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)
- End Date
- Sep 25, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Richardson, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |