Syntho Pharmaceuticals Inc.
United States See location details
Last FDA Action:
Mar 1, 2024
This drug manufacturing facility is registered with the FDA by Hosneara Malik. ProPublica was able to identify at least 2 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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9
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.
8
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 1, 2024Mar 1, 2024
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. - Sep 3, 2019Sep 3, 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.13 citations
Written procedures fail to includeWritten procedures for cleaning and maintenance fail to include maintenance and cleaning schedules, description in sufficient detail of methods, equipment and materials used, description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance, and instructions for removal or obliteration of previous batch identification.Calibration/Inspection/Checking not doneRoutine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.Written Procedures Not FollowedWritten procedures are not followed for the receipt and identification of drug product containers and closures.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Mar 9, 2017Mar 9, 2017Inspection 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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Aug 26, 2016Aug 26, 2016Inspection 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.24 citations
Authority lacking to review records, investigate errorsThe quality control unit lacks authority to fully investigate errors that have occurred.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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Aug 23, 2013Aug 23, 2013Inspection 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.7 citations
Authority lacking to review records, investigate errorsThe quality control unit lacks authority to fully investigate errors that have occurred.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.SOPs not followed / documentedWritten production and process control procedures are not followed in the execution of production and process control functions.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Feb 21, 2012Feb 21, 2012Inspection 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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Nov 28, 2011Nov 28, 2011Inspection 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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Nov 8, 2010Nov 8, 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. - Apr 28, 2010Apr 28, 2010Inspection
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, 2009Feb 3, 2009Inspection 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.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.
CompanyLeading Pharmaceuticals
Dosage
Estrogens
0.625mg
Methyltestosterone
1.25mg
Light blue capsule-shaped tablet marked with 230 SYNTHO
NDC: 69315-283-01
CompanyLeading Pharmaceuticals
Dosage
Estrogens
1.25mg
Methyltestosterone
2.5mg
Light green oval tablet marked with 231 SYNTHO
NDC: 69315-284-01