Mcguff Pharmaceuticals, Inc.
United States See location details
This drug manufacturing facility is registered with the FDA by Mcguff Pharmaceuticals, 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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11
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.
6
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.
- Apr 28, 2025Apr 28, 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
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.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.Procedures for sterile drug productsProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Aug 20, 2024Aug 20, 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. - Jan 26, 2024Jan 26, 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. - Nov 22, 2019Nov 22, 2019Inspection 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
Disinfecting materials, aseptic processing areaEquipment was and Materials or supplies were not disinfected prior to entering the aseptic processing areas.First pass air blockage, open unit with sterile productPersonnel conducted aseptic manipulations in an area that blocked the movement of first pass air around an open unit, either before or after it was filled with sterile product.Flow of personnel and materials, facilityYour facility was designed and/or operated in a way that permits poor flow of personnel and materials.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Mar 26, 2019Mar 26, 2019Inspection 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.7 citations
Training--operations, GMPs, written proceduresEmployees are not given training in the particular operations they perform as part of their function.Defined areas of adequate size for operationsThe separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.Calibration/Inspection/Checking not doneRoutine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Jun 2, 2017Jun 2, 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. - Dec 31, 2014Dec 31, 2014Inspection 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.2 citations
Lack of written stability programThere is no written testing program designed to assess the stability characteristics of drug products.Sterility/pyrogen-free testingEach batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Mar 27, 2014Mar 27, 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. - May 31, 2013May 31, 2013Inspection
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. - Aug 16, 2012Aug 16, 2012Inspection
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. - Aug 24, 2011Aug 24, 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. - Jun 2, 2010Jun 2, 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.