FDA Inspection 1082163 — Navigate BioPharma Services, Inc.
The FDA completed an inspection of Navigate BioPharma Services, Inc. on Mar 1, 2019 in Carlsbad, CA. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 1, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Carlsbad, CA (United States)
Additional details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2984 | 21 CFR 812.140(a)(3)(i) | Investigator records of informed consent inadequate |