Alembic Pharmaceuticals Limited
This drug manufacturing facility is registered with the FDA by Alembic Pharmaceuticals Limited. ProPublica was able to identify at least 32 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.
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.
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 8, 2024Mar 8, 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.4 citations
Written record of investigation incompleteWritten records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.Storage under appropriate conditionsDrug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.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.ProPublica was unable to locate a 483 form detailing issues found in this inspection.