Sharp Sterile Manufacturing, Llc
United States See location details
Last FDA Action:
Jun 12, 2024
This drug manufacturing facility is registered with the FDA by Sharp Sterile Manufacturing, Llc. ProPublica was able to identify at least 1 generic drug 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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5
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.
5
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.
- Jun 12, 2024Jun 12, 2024Inspection 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.4 citations
Released Material AreaSeparate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of released components and labeling.Calibration/Inspection/Checking not doneRoutine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.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 25, 2023Aug 25, 2023Inspection 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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Jan 20, 2023Jan 20, 2023Inspection 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. - May 23, 2022May 23, 2022
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. - Oct 15, 2021Oct 15, 2021Inspection 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.6 citations
Cleaning SystemAseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.Equipment Design, Size and LocationEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size, and suitably located to facilitate operations for its intended use.Certificates of Testing (Containers, Closures)Certificates of testing of containers are accepted in lieu of testing without establishing the reliability of the supplier's test results through appropriate validation of the test results at appropriate intervals.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Oct 27, 2020Oct 27, 2020Inspection 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.6 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.input/output verificationInput to and output from the computer are not checked for accuracy.View Inspector NotesInspector’s notes summarizing deficiencies observed during an 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.
CompanyTrupharma
Dosage
Apomorphine Hydrochloride
30mg/3mL
Injection in a cartridge (3mL)
NDC: 52817-720-X