FDA Inspection
Navinta, LLCNavinta, LLC – FDA Inspection, May 16, 2016
Record Details
This FDA Inspection record concerns Navinta, LLC, with an inspection on May 16, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Navinta, LLC
- Inspection Date
- May 16, 2016
- Product Type
- Drugs
View Company Profile
ID · 00d89d55-9f1e-4732-b227-af5f6a4f6e36
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 971010
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.80(c)(2)Interval
- 21 CFR 314.80(b)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
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
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.