Drug factory · FDA FEI 3004375014

Navinta LLC

1499 Lower Ferry Road, Ewing, NJ, United States

No problems found at FDA's last inspection, Sep 30, 2024.

No Action Indicated: inspectors found no objectionable conditions.

6 drug inspections on record since 2015: 3 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Carmustine	Tests it	Navinta LLC	68475-503
Remifentanil	Tests it	Hikma Pharmaceuticals USA Inc.	0143-9391, 0143-9392, 0143-9393

Ended	Result	Program	Problems noted
Sep 30, 2024	No problems found	Drug Quality Assurance	—
May 4, 2023	No problems found	Bioresearch Monitoring	—
Mar 28, 2019	Problems found, fixed voluntarily	Bioresearch Monitoring	1
Aug 18, 2017	Problems found, fixed voluntarily	Postmarket Surv. and Epidemiology	4
May 16, 2016	Serious problems, FDA action	Bioresearch Monitoring	3
Aug 10, 2015	No problems found	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Failure to submit scientific article 21 CFR 314.80(d)
A postmarketing 15-day Alert report based upon scientific literature was not accompanied by a copy of the published article.

Late submission of 15-day report 21 CFR 314.80(c)(1)(i)
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
Incomplete periodic safety report 21 CFR 314.80(c)(2)(ii)(A)
You failed to submit a periodic report containing an analysis of the post marketing 15-day Alert reports submitted during the reporting interval and an index with a line listing of your patient identification code and adverse reaction term(s) for all ICSRs you submitted for the reporting interval.
Late submission of an ICSR 21 CFR 314.80(c)(2)(ii)(B)
You failed to submit an ICSR for the reporting period within 60 days of the anniversary date of the approval of the application.
Failure to maintain records 21 CFR 314.80(j)
You failed to maintain for a period of 10 years records of all adverse drug experiences known to you, including raw data and any correspondence.

Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the surveillance , receipt , evaluation and reporting to FDA of post marketing adverse drug experiences.
Interval 21 CFR 314.80(c)(2)
Periodic reports of non-alert adverse drug experiences have not been submitted quarterly for an application which was approved less than three years ago and yearly for an application which was approved three or more years ago .
Timely submission 21 CFR 314.81(b)(2)
An annual report was not submitted each year and within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application.

Registered with FDA for: analysis; api manufacture.