Hetero Labs Limited
India See location details
Last FDA Action:
Jul 21, 2023
This drug manufacturing facility is registered with the FDA by Hetero Labs Limited. ProPublica was able to identify at least 432 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
8
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.
7
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.
- Jul 21, 2023Jul 21, 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.2 citations
Written record of investigation incompleteWritten records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.Complete test data included in recordsLaboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Jun 7, 2019Jun 7, 2019Inspection 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.10 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Computer control of master formula recordsAppropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.Absence of Written ProceduresThere are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Oct 26, 2018Oct 26, 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. - Mar 23, 2018Mar 23, 2018Inspection With Issues
The FDA determined this facility was in an acceptable state, though an inspector documented issues.
The FDA ultimately considered the facility to be in an acceptable state of compliance, which is the best possible outcome for an inspection. It’s impossible to know exactly what happened in this case, but an inspector filed a 483 report documenting issues, possibly as a part of a concurrent inspection that we don’t have an outcome for.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Oct 26, 2016Oct 26, 2016Inspection 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. - Jul 31, 2015Jul 31, 2015Inspection 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. - Oct 11, 2013Oct 11, 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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Dec 15, 2011Dec 15, 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. - Nov 2, 2009Nov 2, 2009Inspection 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.
CompanyCamber Pharmaceuticals
Dosage
Abacavir Sulfate
20mg/mL
Clear yellowish strawberry-banana-flavored solution in a bottle (240mL)
NDC: 31722-562-24
CompanyAvpak
Dosage
Abacavir Sulfate
300mg
Yellow capsule-shaped tablet marked with H 139
NDC: 50268-049-X
CompanyCamber Pharmaceuticals
Dosage
Abacavir Sulfate
300mg
Yellow capsule-shaped tablet marked with H 139
NDC: 31722-557-60
CompanyCamber Pharmaceuticals
Dosage
200mg/5mL
White to off white banana-flavored suspension in a bottle (473mL)
NDC: 31722-681-47
CompanyAtlantic Biologicals
Dosage
1mg/mL
Orange-flavored solution in a cup, unit-dose (5mL)
NDC: 17856-0684-X
CompanyCamber Pharmaceuticals
Dosage
1mg/mL
Orange-flavored solution in a bottle (150mL)
NDC: 31722-684-15
CompanyNorthstar Rx
Dosage
1mg/mL
Orange-flavored solution in a bottle (150mL)
NDC: 72603-445-01
CompanyCamber Pharmaceuticals
Dosage
Atazanavir Sulfate
150mg
Light green capsule marked with H A6
NDC: 31722-653-X
CompanyCamber Pharmaceuticals
Dosage
Atazanavir Sulfate
200mg
Light green capsule marked with H A7
NDC: 31722-654-X
CompanyCamber Pharmaceuticals
Dosage
Atazanavir Sulfate
300mg
Orange, green capsule marked with H A8
NDC: 31722-655-X
CompanyLohxa
Dosage
750mg/5mL
Yellow strawberry-flavored suspension in a syringe, plastic (5mL)
NDC: 70166-488-X
CompanyAmerican Health Packaging
Dosage
750mg/5mL
Yellow strawberry-flavored suspension in a cup, unit-dose (5mL)
NDC: 60687-534-X
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