Novel Laboratories, Inc.
This drug manufacturing facility is registered with the FDA by Novel Laboratories Inc. ProPublica was able to identify at least 174 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.
14
Known Inspections
The inspections we were able to locate using available FDA data do not include inspections in advance of the release of a new drug product.
10
Inspections Found Issues
When issues are observed, inspectors usually file an FDA 483 form with citations. In more serious cases, the FDA can issue warning letters or even ban the import of drugs from the facility.
- May 17, 2024May 17, 2024Inspection
The FDA determined this facility was in an acceptable state.
This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors. - Apr 19, 2023Apr 19, 2023Warning Letter Close-Out
The FDA said issues raised in a previous warning letter were fixed.
This “close-out letter,” which the FDA sometimes publishes, indicates the agency has verified that the company addressed its deficiencies. - Jan 13, 2023Jan 13, 2023Inspection With Issues
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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Mar 30, 2022Mar 30, 2022Inspection With Issues
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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Jun 11, 2021Jun 11, 2021Warning Letter
The FDA issued a warning letter laying out significant issues.
The letter is a disciplinary tool the FDA uses to lay out significant violations of manufacturing standards and to outline needed improvements. It often includes a summary of the steps the company had initially pledged to take to correct issues identified during inspections. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public. - Nov 5, 2020Nov 5, 2020Inspection With Issues
The FDA ruled the facility was in an “unacceptable state of compliance.”
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. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Dec 21, 2018Dec 21, 2018
An inspector documented issues at the facility.
We were unable to connect this 483 form to an FDA inspection designation, but we do know that an inspector filed this form observing problem(s).View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Nov 8, 2018Nov 8, 2018Inspection With Issues
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.3 citations
Late submission of annual safety reportsNot all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.Late submission of quarterly safety reportsNot all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.Timely submissionAn annual report was not submitted within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Feb 23, 2018Feb 23, 2018Inspection With Issues
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.4 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Defined areas of adequate size for operationsThe separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.Equipment Design, Size and LocationEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size, and suitably located to facilitate operations for its intended use.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Aug 8, 2017Aug 8, 2017Inspection With Issues
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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Feb 14, 2017Feb 14, 2017Inspection
The FDA determined this facility was in an acceptable state.
This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors. - Nov 17, 2015Nov 17, 2015Inspection
The FDA determined this facility was in an acceptable state.
This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors. - Jan 22, 2015Jan 22, 2015Inspection
The FDA determined this facility was in an acceptable state.
This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors. - Jun 24, 2014Jun 24, 2014Inspection With Issues
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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Aug 26, 2013Aug 26, 2013Inspection With Issues
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.13 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Training--operations, GMPs, written proceduresEmployees are not given training in the particular operations they perform as part of their function.Defined areas of adequate size for operationsThe separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Jun 29, 2011Jun 29, 2011Inspection With Issues
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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Mar 5, 2010Mar 5, 2010Inspection With Issues
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.ProPublica was unable to locate a 483 form detailing issues found in this inspection.
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.
CompanyLupin Pharmaceuticals
Dosage
Amlodipine Besylate
10mg
Valsartan
160mg
White oval tablet marked with N82
NDC: 43386-082-X
CompanyLupin Pharmaceuticals
Dosage
Amlodipine Besylate
5mg
Valsartan
320mg
White oval tablet marked with N81
NDC: 43386-081-X
CompanyLupin Pharmaceuticals
Dosage
Amlodipine Besylate
5mg
Valsartan
160mg
White oval tablet marked with N83
NDC: 43386-083-X
CompanyLupin Pharmaceuticals
Dosage
Amlodipine Besylate
10mg
Valsartan
320mg
White oval tablet marked with N08
NDC: 43386-080-X
CompanyLupin Pharmaceuticals
Dosage
25mg
Orange round tablet marked with nl c
NDC: 43386-980-X
CompanyNovel Laboratories
Dosage
25mg
Orange round tablet marked with nl c
NDC: 40032-980-X
CompanyLupin Pharmaceuticals
Dosage
30mg
Brown (tan) capsule marked with NL999 30mg
NDC: 43386-999-X
CompanyNovel Laboratories
Dosage
30mg
Brown (tan) capsule marked with NL999 30mg
NDC: 40032-999-X
CompanyNovel Laboratories
Dosage
0.05%
Off-white ointment in a tube (15g)
NDC: 40032-096-X
CompanyLupin Pharmaceuticals
Dosage
0.05%
Solution in a bottle (50mL)
NDC: 43386-028-X
CompanyNovel Laboratories
Dosage
0.05%
Solution in a bottle (50mL)
NDC: 40032-028-60
CompanyLupin Pharmaceuticals
Dosage
0.05%
Off-white ointment in a tube (15g)
NDC: 43386-096-X
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