FDA Inspection
Navinta, LLCNavinta, LLC – FDA Inspection, Mar 28, 2019
Record Details
This FDA Inspection record concerns Navinta, LLC, with an inspection on March 28, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e5f0a259-43ef-4701-adfe-5b2f94d30760
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1084188
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 314.80(d)Failure to submit scientific article
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Other FDA inspections of Navinta, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2024 | Not classified | New Jersey District Office | |
| June 29, 2023 | Not classified | New Jersey District Office | |
| May 4, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 18, 2018 | Not classified | New Jersey District Office | |
| August 18, 2017 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
Other documents for Navinta, LLC
- FDA Inspection 1252822 - 2024-09-30
- FDA Inspection 1209856 - 2023-06-29
- FDA Inspection 1205480 - 2023-05-04
- FDA Inspection 1070302 - 2018-09-18
- FDA Inspection 1022105 - 2017-08-18
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