1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Alembic Pharmaceuticals Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drng products is not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use and cleaning and maintenance.
3Equipment and facility
Equipment for adequate control over air pressme is not provided when appropriate for the manufacture, processing, packing or holding ofa drng product.
4Aseptic processing and sterility assurance
Procedmes designed to prevent microbiological contamination of chug products purpo1i ing to be sterile did not include adequate validation of the aseptic and sterilization process.
5Quality unit oversight
The quality control unit lacks authority to fully investigate en ors that have occuned.
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.
