L. Perrigo Company
United States See location details
This drug manufacturing facility is registered with the FDA by L. Perrigo Company.
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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19
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.
10
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 19, 2025Mar 19, 2025Inspection 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
Written sanitation procedures not followedWritten procedures for sanitation are not followed.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.Computer control of master formula recordsAppropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Oct 6, 2023Oct 6, 2023Inspection
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 17, 2019Jan 17, 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.8 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.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.Procedures for non-sterile drug productsProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Dec 11, 2014Dec 11, 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. - Sep 4, 2014Sep 4, 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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Nov 7, 2013Nov 7, 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.2 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.Packaging line inspection after useInspection of the packaging and labeling facilities is not done after use to assure that materials not suitable for subsequent operations have been removed.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - May 17, 2013May 17, 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. - Jul 10, 2012Jul 10, 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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Jun 7, 2012Jun 7, 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. - May 8, 2012May 8, 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. - Mar 21, 2011Mar 21, 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
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.Extent of discrepancy, failure investigationsInvestigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Mar 9, 2011Mar 9, 2011Inspection
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. - Jun 28, 2010Jun 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. - Mar 17, 2010Mar 17, 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 11, 2010Feb 11, 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
Filling, assembling, packing controlsFailure to perform filling and packaging in a manner that protects food from becoming contaminated.Buildings of Suitable Size, Construction, LocationBuildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.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. - Jan 14, 2010Jan 14, 2010Inspection 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. - Jan 27, 2009Jan 27, 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.5 citations
Q.C. instrument accuracy, maintenanceInstruments used for measuring conditions that control or prevent the growth of undesirable microorganisms are not adequately maintained.Teardown equipment/thorough cleaningFailure to take apart equipment as necessary to ensure thorough cleaning.Manufacturing conditionsFailure to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Jan 16, 2009Jan 16, 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. - Nov 7, 2008Nov 7, 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.10 citations
Approve or reject components, productsThe quality control unit lacks the responsibility and authority to reject all drug products.Contract drug products--lack of responsibilityThe quality control unit lacks responsibility for approving or rejecting drug products manufactured under contract by another company.Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.ProPublica was unable to locate a 483 form detailing issues found in this inspection.