FDA Inspection 601980 — Oceanic Medical Products, Inc.
The FDA completed an inspection of Oceanic Medical Products, Inc. on Aug 4, 2009 in Atchison, 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
- Aug 4, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Atchison, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2429 | 21 CFR 820.30(b) | Establish the design and development plan |
| 2602 | 21 CFR 820.30(d) | Design output - review and approval |
| 3673 | 21 CFR 820.30(c) | Design input approval documentation |