1Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Inspection Record
Granules India Ltd. — FDA 483 Findings
Inspectors Joseph A. PiechockiThe 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 and utensils are not cleaned at appropriate intervals to prevent that would a lter the sa fety, identity, strength, quality or purity ofthe drug product.
3Process validation
TYPE ESTABLISHMENT INSPECTED Drug Product Manuf ac t urer Written procedures are not followed that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch.
4Deviation, 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 ofits specifications whether or not the batch has been already distributed.
About this record
Extracted automatically from the document US FDA published on 2024-09-17. 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.
