FDA Inspection 1061706 — Oceanic Medical Products, Inc.
The FDA completed an inspection of Oceanic Medical Products, Inc. on Aug 10, 2018 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 10, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Atchison, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |