Professional Disposables International, Inc.
United States See location details
This drug manufacturing facility is registered with the FDA by Professional Disposables International, Inc..
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.
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.
- Dec 12, 2024Dec 12, 2024Warning Letter Close-Out
The FDA said issues raised in a previous warning letter were fixed.
This “close-out letter,” which the FDA sometimes publishes, indicates the agency has verified that the company addressed its deficiencies. - Jan 7, 2022Jan 7, 2022Warning 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. - Jun 23, 2021Jun 23, 2021Inspection 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. - May 28, 2019May 28, 2019
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. - Dec 1, 2017Dec 1, 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.2 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.Failure to meet specificationsAn NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Dec 9, 2015Dec 9, 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.1 citation
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. - Oct 18, 2011Oct 18, 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.8 citations
Training , Education , Experience overallEmployees engaged in the manufacture of a drug product lack the training required to perform their assigned functions.Written procedures not established/followedWritten procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.Lab controls established, including changesThe establishment of specifications and test procedures including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Jul 5, 2011Jul 5, 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.2 citations
Microbiological Contamination ExamEach lot of a component that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.Sample size - test intervalsThe written stability program for drug products does not include sample size based on statistical criteria for each attribute examined to assure valid estimates of stability.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Apr 20, 2011Apr 20, 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.2 citations
SOPs not followed / documentedWritten production and process control procedures are not followed in the execution of production and process control functions.Investigations of discrepancies, failuresThere is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Oct 21, 2010Oct 21, 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.3 citations
SOPs not followed / documentedWritten production and process control procedures are not followed in the execution of production and process control functions.Written warehousing procedures established/followedProcedures describing the warehousing of drug products are not established.Investigations of discrepancies, failuresThere is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Oct 29, 2008Oct 29, 2008Inspection 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.4 citations
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.Review of representative number of batchesWritten procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.Theoretical yield statement including percentagesMaster production and control records lack a statement of theoretical yield including the maximum and minimum percentages of theoretical yield beyond which investigation is required.ProPublica was unable to locate a 483 form detailing issues found in this inspection.