FDA Inspection 1022105 — Navinta, LLC
The FDA completed an inspection of Navinta, LLC on August 18, 2017 in Ewing, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 18, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Postmarket Surv. and Epidemiology
- Location
- Ewing, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18025 | 21 CFR 314.80(c)(2)(ii)(B) | Late submission of an ICSR |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 6833 | 21 CFR 314.80(c)(2)(ii)(A) | Incomplete periodic safety report |
| 6842 | 21 CFR 314.80(j) | Failure to maintain records |