FDA Inspection 613365 — Kale Research & Technology
The FDA completed an inspection of Kale Research & Technology on August 26, 2009 in Mount Pleasant, SC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 26, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mount Pleasant, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2429 | 21 CFR 820.30(b) | Establish the design and development plan |