Winder Laboratories, Llc
This drug manufacturing facility is registered with the FDA by Winder Laboratories, Llc. ProPublica was able to identify at least 33 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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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.
5
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.
- Aug 5, 2025Aug 5, 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.13 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.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.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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Feb 5, 2025Feb 5, 2025Inspection
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. - Feb 3, 2023Feb 3, 2023
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 13, 2020Mar 13, 2020Inspection 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.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.Objectionable microbiological contaminationEach lot of a component liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use.Investigations of discrepancies, failuresThere is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Jul 18, 2018Jul 18, 2018Inspection 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. - Jun 9, 2017Jun 9, 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. - Feb 25, 2016Feb 25, 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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Dec 3, 2015Dec 3, 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.10 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.GMP Training FrequencyGMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.Training--operations, GMPs, written proceduresEmployees are not given training in the particular operations they perform as part of their function.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Feb 10, 2009Feb 10, 2009Inspection
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.
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.
CompanyWinder Laboratories
Dosage
Chlordiazepoxide Hydrochloride
5mg
Clidinium Bromide
2.5mg
White capsule marked with WL 134
NDC: 75826-134-10
CompanyWinder Laboratories
Dosage
2.5mg
White oval tablet marked with WL 2 5
NDC: 75826-120-X
CompanyWinder Laboratories
Dosage
7.5mg
Light green oval tablet marked with WL 7 5
NDC: 75826-122-X
CompanyWinder Laboratories
Dosage
10mg
Orange (peach) oval tablet marked with WL 10
NDC: 75826-123-X
CompanyWinder Laboratories
Dosage
20mg
Purple oval tablet marked with WL 20
NDC: 75826-125-X
CompanyWinder Laboratories
Dosage
30mg
Light yellow oval tablet marked with WL 30
NDC: 75826-126-X
CompanyWinder Laboratories
Dosage
5mg
Pink oval tablet marked with WL 5
NDC: 75826-121-X
CompanyWinder Laboratories
Dosage
15mg
Light blue oval tablet marked with WL 15
NDC: 75826-124-X
CompanyWinder Laboratories
Dosage
Diphenoxylate Hydrochloride
2.5mg
Atropine Sulfate
0.025mg
White round tablet marked with WL 107
NDC: 75826-107-X
CompanyWinder Laboratories
Dosage
Sodium Fluoride
1mg
Purple-colored natural grape flavor-flavored round tablet, chewable marked with WL165
NDC: 75826-165-20
CompanyWinder Laboratories
Dosage
Sodium Fluoride
0.25mg
Pink-colored natural grape flavor-flavored round tablet, chewable marked with WL163
NDC: 75826-163-20
CompanyWinder Laboratories
Dosage
Sodium Fluoride
0.5mg
Orange (peach-colored) natural grape flavor-flavored round tablet, chewable marked with WL164
NDC: 75826-164-20
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