FDA Inspection 800774 — LED Technologies, LLC
The FDA completed an inspection of LED Technologies, LLC on Sep 25, 2012 in Greenwood Village, CO. 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). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 25, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Greenwood Village, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |