FDA Inspection
Navidea Biopharmaceuticals IncNavidea Biopharmaceuticals Inc – FDA Inspection, May 21, 2015
Record Details
This FDA Inspection record concerns Navidea Biopharmaceuticals Inc, with an inspection on May 21, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 21, 2015
- Product Type
- Drugs
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ID · 6d6a026a-8a30-4ac1-8641-25e90c371baf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 928851
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Navidea Biopharmaceuticals Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 4, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 15, 2011 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 28, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Navidea Biopharmaceuticals Inc
- FDA Inspection 1028545 - 2017-08-11
- FDA Inspection 914332 - 2015-02-04
- FDA Inspection 760549 - 2011-12-15
- FDA Inspection 747197 - 2011-09-28
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