FDA Inspection 729522 — NDC HomeCare, LLC
The FDA completed an inspection of NDC HomeCare, LLC on May 10, 2011 in Kansas City, KS. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 10, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kansas City, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |