FDA Inspection 1086057 — CoRE labs, LLC
The FDA completed an inspection of CoRE labs, LLC on April 11, 2019 in Englewood, CO. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 11, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Englewood, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 5007 | 21 CFR 1002.13 | Failure to submit |