FDA Inspection 896798 — Incumedx LLC
The FDA completed an inspection of Incumedx LLC on September 12, 2014 in Fremont, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 12, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Fremont, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 3900 | 21 CFR 58.10 | Notifying contractor of GLP status |
| 3996 | 21 CFR 58.120(a)(3) | Protocol: sponsor name and address |
| 3999 | 21 CFR 58.120(a)(6) | Protocol: experimental design |
| 4004 | 21 CFR 58.120(a)(11) | Protocol: date and signature |
| 4017 | 21 CFR 58.185(a)(1) | Final report: name, address, dates |
| 4022 | 21 CFR 58.185(a)(6) | Final report: description of methods |
| 4031 | 21 CFR 58.185(b) | Final report: not signed by study director |
| 4035 | 21 CFR 58.190(a) | Archives: data, documentation, specimens |