FDA Inspection
Navinta, LLCNavinta, LLC – FDA Inspection, Aug 18, 2017
Record Details
This FDA Inspection record concerns Navinta, LLC, with an inspection on August 18, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d7b6f6e5-255c-431f-99a7-3598a3c0f4ca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1022105
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(j)Failure to maintain records
- 21 CFR 314.80(c)(2)(ii)(B)Late submission of an ICSR
- 21 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report
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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 |
| March 28, 2019 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 18, 2018 | Not classified | New Jersey District Office |
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 1084188 - 2019-03-28
- FDA Inspection 1070302 - 2018-09-18
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