FDA Inspection 975851 — Cleartooth Electronics, Inc.
The FDA completed an inspection of Cleartooth Electronics, Inc. on Mar 17, 2016 in Boulder, CO. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 17, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Boulder, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |