1Documentation and records
Batch production and conti·ol records do not include complete info1mation relating to the production and conti-ol of each batch.
Inspection Record
Glenmark Pharmaceuticals Ltd. — FDA 483 Findings
Inspectors Justin A Boyd · Jose M CayuelaThe inspectors who signed the published document.Inspector lookup
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 to facilitate operations for its intended use and cleaning and maintenance.
3Deviation, CAPA, and investigation
fuvestigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same diug product and other di11g products that may have been associated with the specific failure or discrepancy.
4Laboratory and QC controls
Laborato1y controls do not include the establishment ofscientifically sound and appropriate test procedures designed to assure that diug products confo1m to appropriate standards of identity, strength, quality and purity.
About this record
Extracted automatically from the document US FDA published on 2022-12-28. 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.
