1Laboratory and QC controls
Verification of the suitability ofthe testing methods is deficient in that they are not perfo1med under actual conditions of use.
Inspection Record
Alembic Pharmaceuticals Limited — FDA 483 Findings
Inspectors Yvins DezanThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Written records ai·e not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
3Validation and qualification
Procedures designed to prevent microbiol~ontamination of diug products purpo1iing to be did not include adequate validation of th~ rocess.
4Other quality system
processing areas are deficient regarding the system for cleaning and disinfecting the room and ent to produce~ onditions.
5Quality unit oversight
The responsibilities and procedmes applicable to the quality control unit are not in writing and fully followed.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
7Equipment and facility
cessing areas are deficient regarding systems for maintaining any equipment used to control 1liellllllllconditions.
8Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already disti-ibuted.
9Process validation
Control procedures are not established which monitor the output and validate the perfo1mance ofthose manufacturing processes that may be responsible for causing variability in the characteristics of in process material and the diug product.
10Computer system validation
Appropriate controls are not exercised over computers or related systems to assme that changes in master production and contrnl records or other records are instituted only by authorized personnel.
About this record
Extracted automatically from the document US FDA published on 2026-01-07. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
