FDA Inspection 663013 — We Care Designs LLC
The FDA completed an inspection of We Care Designs LLC on May 19, 2010 in Mandeville, LA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 19, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mandeville, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4189 | 21 CFR 820.198(a) | General |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |