1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Sun Pharmaceutical Industries Ltd. — FDA 483 Findings
Inspectors Dongping DaiThe 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
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been aheady distributed.
3Process validation
There are no written procedures for production and process controls designed to assure that the chug products have the identity, strength, quality, and purity they pmpo1t or are represented to possess.
4Process validation
Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drng product.
5Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drng products confo1m to appropriate standards of identity, strength, quality and purity.
6Material and supplier control
Written procedures are not established and followed that describe the examinations to be conducted on appropriate samples of in-process materials of each batch.
7Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diug products purpo1i ing to be sterile are not established, written and followed.
About this record
Extracted automatically from the document US FDA published on 2019-12-20. 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.
