Altaire Pharmaceuticals Inc.
This drug manufacturing facility is registered with the FDA by Altaire Pharmaceuticals Inc.. ProPublica was able to identify at least 4 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.
12
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.
- Feb 11, 2022Feb 11, 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Mar 12, 2020Mar 12, 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 19, 2019Apr 19, 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. - Mar 9, 2017Mar 9, 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.5 citations
Control procedures to monitor and validate performanceControl procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.Procedures for sterile drug productsProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written.Scientifically sound laboratory controlsLaboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials conform to appropriate standards of identity, strength, quality and purity.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Dec 15, 2015Dec 15, 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.5 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Retest of approved components/containers/closuresApproved components are not retested or reexamined as appropriate for identity, strength, quality and purity after storage for long periods with subsequent approval or rejection by the quality control unit.Procedures for sterile drug productsProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Apr 13, 2015Apr 13, 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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Jul 29, 2014Jul 29, 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.8 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Sanitation--buildings not clean, free of infestationBuildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.Written Procedures Not FollowedWritten procedures are not followed for the receipt and identification of drug product containers and closures.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Aug 8, 2013Aug 8, 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.7 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Sanitation--buildings not clean, free of infestationBuildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.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. - Jun 7, 2012Jun 7, 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.5 citations
Protective Apparel Not WornProtective apparel is not worn as necessary to protect drug products from contamination.Control procedures to monitor and validate performanceControl procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.Drug products-sampling procedures/specificationsLaboratory controls do not include a determination of conformance to written descriptions of sampling procedures for drug products.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Mar 19, 2012Mar 19, 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.10 citations
Laboratory operations: electronicYour electronic records for your laboratory operations do not comply with the electronic records requirements.Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Protective Apparel Not WornProtective apparel is not worn as necessary to protect drug products from contamination.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Nov 19, 2010Nov 19, 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.12 citations
Protective Apparel Not WornProtective apparel is not worn as necessary to protect drug products from contamination.Equipment for Environmental ControlEquipment for adequate control over temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.Sanitation--buildings not clean, free of infestationBuildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Feb 4, 2010Feb 4, 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.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.Protective Apparel Not WornProtective apparel is not worn as necessary to protect drug products from contamination.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Apr 28, 2009Apr 28, 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.
CompanyAltaire Pharmaceuticals
Dosage
Ciprofloxacin Hydrochloride
0.3%
Solution in a bottle, plastic (2.5mL)
NDC: 59390-217-X
CompanyAltaire Pharmaceuticals
Dosage
Diclofenac Sodium
0.1%
Solution/ drops in a bottle, dropper (2.5mL)
NDC: 59390-149-X
CompanyAltaire Pharmaceuticals
Dosage
Fluorescein Sodium
0.25%
Proparacaine Hydrochloride
0.5%
Solution/ drops in a bottle, dropper (5mL)
NDC: 59390-205-05
CompanyAltaire Pharmaceuticals
Dosage
Ofloxacin
0.3%
Solution in a bottle, dropper (5mL)
NDC: 59390-140-05