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Ingenus Pharmaceuticals Nj, Llc

United States See location details

This drug manufacturing facility is registered with the FDA by Ingenus Pharmaceuticals Nj, Llc. ProPublica was able to identify at least 80 generic drugs that have been manufactured at this facility.

Facility Inspection History

The FDA is responsible for inspecting drug manufacturing facilities for violations of good manufacturing practices, such as a lack of documented drug quality testing or contaminated equipment. Below is a timeline of FDA inspections and outcomes for this facility assembled by ProPublica.

Note: ProPublica does not provide medical advice. Stopping your medication, doctors warn, can be dangerous. Please consult your doctor first if you have concerns. Read more

Drugs Manufactured Here

Below is a list of generic prescription drugs that we’ve been able to connect to this facility. Brand name and over-the-counter drugs, as well as labels we were unable to trace, are not included here.

Bismuth Subcitrate Potassium, Metronidazole, Tetracycline Hydrochloride

CompanyIngenus Pharmaceuticals
Dosage
Bismuth Subcitrate Potassium
140mg
Metronidazole
125mg
Body and a white cap capsule marked with ING283
NDC: 50742-283-13

Carbamazepine

CompanyIngenus Pharmaceuticals
Dosage
100mg
White round tablet, extended release marked with I 257
NDC: 50742-257-01

Carbamazepine

CompanyIngenus Pharmaceuticals
Dosage
200mg
White round tablet, extended release marked with I258
NDC: 50742-258-01

Carbamazepine

CompanyIngenus Pharmaceuticals
Dosage
400mg
White round tablet, extended release marked with I259
NDC: 50742-259-01

Carisoprodol

CompanyIngenus Pharmaceuticals
Dosage
350mg
White round tablet marked with CL 022
NDC: 50742-656-X

Cevimeline Hydrochloride

CompanyRising Pharma Holdings
Dosage
30mg
White cap and body capsule marked with P 657
NDC: 16571-657-10

Cevimeline Hydrochloride

CompanyBryant Ranch Prepack
Dosage
30mg
White cap and body capsule marked with P 657
NDC: 63629-9863-X

Chlorthalidone

CompanyRising Pharma Holdings
Dosage
25mg
Green round tablet marked with 010
NDC: 64980-303-X

Chlorthalidone

CompanyAphena Pharma Solutions - Tennessee
Dosage
25mg
Green round tablet marked with 010
NDC: 71610-472-X

Chlorthalidone

CompanyRising Pharma Holdings
Dosage
50mg
Green capsule-shaped tablet marked with 011
NDC: 64980-304-01

Colestipol Hydrochloride

CompanyIngenus Pharmaceuticals
Dosage
1g
Pale yellow to yellow oval tablet, film coated marked with I
NDC: 50742-284-12

Desipramine Hcl

CompanyDirect_rx
Dosage
Desipramine Hydrochloride
10mg
White round tablet marked with ING 112
NDC: 72189-391-30

Frequently Asked Questions

What Do the Inspection Outcomes Mean?
These are the possible FDA compliance outcomes we highlight:
  • Import alert. This is rare and means drugs from this facility were banned from coming into the U.S. Specifically we are including alerts relating to FDA manufacturing standards for drug products. The agency sometimes exempts certain drugs from import bans, ostensibly to prevent drug shortages.
  • Warning letter. This is a disciplinary tool the FDA uses to lay out significant violations of federal requirements. The company has an opportunity to respond and/or provide its plans to correct the issues. The agency might later issue a “close-out letter” to say it has confirmed that issues raised in a previous warning letter were fixed. But that doesn’t always happen.
  • Unacceptable state of compliance. This means inspectors found serious issues at the facility and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. The agency classifies this as “official action indicated.”
  • Some issues found, but no further FDA action. This is very common. It means the FDA found issues but determined the facility can correct them voluntarily. In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time. The agency classifies this as “voluntary action indicated.”
  • Inspector documented issues. Inspectors can file notes summarizing deficiencies observed during an inspection using a 483 form. In some cases, we’re unable to connect a Form 483 to an FDA inspection designation, but we show that an inspector filed this form, perhaps as part of an inspection that was not included in the public inspection dashboard.
  • Acceptable state. This is common and the best possible outcome for an inspection. This means the FDA took no compliance action and ProPublica found no issues documented by inspectors. That doesn’t always mean no issues turned up. Sometimes, inspectors address concerns with management on site that they believe do not need to be documented on a 483. The agency classifies this as “no action indicated.”
There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.

How Did ProPublica Connect This Information?
We have written an in-depth methodology, but in short, we connected several FDA databases:
  • The Structured Product Labeling database.
  • The National Drug Code Directory.
  • The Electronic Drug Registration and Listing System.
  • Data from the agency’s inspection dashboard.
  • A spreadsheet of facility addresses we sued the FDA for, which connected them to drug application numbers.
  • Form 483 documents we received from a Freedom of Information Act Request.
ProPublica described the app and the methodology used to build it to the FDA, which did not comment. The agency previously told ProPublica that it doesn’t reveal where drugs are made on inspection reports to protect what it deemed confidential commercial information.

How Do I Report Incorrect Information?
If you work for a manufacturer or otherwise see that information we are displaying may be incorrect, please email [email protected].