FDA Inspection 643636 — Koko, LLC
The FDA completed an inspection of Koko, LLC on February 9, 2010 in Longmont, CO. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 9, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Longmont, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |
| 4189 | 21 CFR 820.198(a) | General |