Navinta LLC
Form 483 issued March 28, 2019 · Ewing, New Jersey
- Inspection
- Mar 25 – Mar 28, 2019
- Observations
- 1
- Pages
- 3
- FEI number
- 3004375014
In short: On March 28, 2019, FDA issued a Form 483 with 1 observation to Navinta LLC in Ewing, New Jersey (FEI 3004375014) after an inspection that ran Mar 25 – Mar 28, 2019. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observation- 01
A postmarketing 15-day Alert report based upon scientific literature was not accompanied by a copy…
This inspection in context
Questions about this 483
What did FDA find at Navinta LLC?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
When was Navinta LLC inspected by FDA?
The inspection ran Mar 25 – Mar 28, 2019, and the Form 483 is dated March 28, 2019.
How do I get the full Form 483 for Navinta LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.