Kvk-tech, Inc.
This drug manufacturing facility is registered with the FDA by Kvk-tech, 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.
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12
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.
9
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.
- Mar 14, 2025Mar 14, 2025Inspection 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.4 citations
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.Cleaning / Sanitizing / MaintenanceEquipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.Test methodsThe accuracy, sensitivity, specificity, and reproducibility of test methods have not been established.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Oct 21, 2024Oct 21, 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. - Jul 8, 2022Jul 8, 2022Inspection 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.10 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Buildings of Suitable Size, Construction, LocationBuildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.Buildings not maintained in good state of repairBuildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Jun 11, 2021Jun 11, 2021
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. - Feb 11, 2020Feb 11, 2020Warning 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. - Apr 16, 2019Apr 16, 2019Inspection 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. - Sep 21, 2018Sep 21, 2018Inspection
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 27, 2017Jun 27, 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. - Dec 11, 2014Dec 11, 2014Inspection
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. - Dec 9, 2013Dec 9, 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. - Sep 17, 2012Sep 17, 2012Inspection 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 1, 2011Aug 1, 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. - Dec 16, 2009Dec 16, 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. - Aug 31, 2009Aug 31, 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.
CompanyKvk-tech
Dosage
Atovaquone
750mg/5mL
Bright yellow citrus-flavored suspension in a bottle, plastic (210mL)
NDC: 10702-223-21
CompanyPd-rx Pharmaceuticals
Dosage
50mg
Orange (peach) round tablet marked with K 40
NDC: 43063-541-X
CompanyKvk-tech
Dosage
50mg
Orange (peach) round tablet marked with K 40
NDC: 10702-040-X
CompanyBryant Ranch Prepack
Dosage
50mg
Orange (peach) round tablet marked with K 40
NDC: 71335-0451-X
CompanyCalvin Scott & Co
Dosage
50mg
Orange (peach) round tablet marked with K 40
NDC: 17224-672-X
CompanyKvk-tech
Dosage
10mg
White round tablet, coated marked with K 13
NDC: 10702-013-01
CompanyKvk-tech
Dosage
20mg
White round tablet, coated marked with K 14
NDC: 10702-014-01
CompanyA-s Medication Solutions
Dosage
Butalbital
50mg
Acetaminophen
325mg
White round tablet marked with C17
NDC: 50090-7519-0
CompanyKvk-tech
Dosage
Butalbital
50mg
Acetaminophen
325mg
White round tablet marked with C17
NDC: 10702-253-X
CompanyBryant Ranch Prepack
Dosage
Butalbital
50mg
Acetaminophen
325mg
White round tablet marked with C17
NDC: 71335-9603-X
CompanyAphena Pharma Solutions - Tennessee
Dosage
10mg
Yellow round tablet, film coated marked with K 7
NDC: 71610-016-X
CompanyProficient Rx Lp
Dosage
5mg
Orange round tablet, film coated marked with K 6
NDC: 63187-094-X
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