FDA Inspection
Navigate BioPharma Services, Inc.Navigate BioPharma Services, Inc. – FDA Inspection, Mar 1, 2019
Record Details
This FDA Inspection record concerns Navigate BioPharma Services, Inc., with an inspection on March 1, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4c27b9e5-916f-479c-a69b-f1f80e3909d5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1082163
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.140(a)(3)(i)Investigator records of informed consent inadequate
- 21 CFR 812.40Sponsors' general responsibilities
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Other FDA inspections of Navigate BioPharma Services, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Navigate BioPharma Services, Inc.
- FDA Inspection 1082309 - 2019-02-21
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