FDA Inspection 800074 — OralDNA Labs, Inc. A Quest Diagnostics Company
The FDA completed an inspection of OralDNA Labs, Inc. A Quest Diagnostics Company on September 17, 2012 in Brentwood, TN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 17, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Brentwood, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |