1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
Inspection Record
Shilpa Medicare Limited — FDA 483 Findings
Inspectors Joseph A. Piechocki · Youkeun KimThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
The separate or defined areas and control systems necessru.y to prevent contamination or mix-ups are deficient.
3Aseptic processing and sterility assurance
Procedmes designed to prevent microbiological contamination of diu g products pmpo1iing to be sterile are not established and followed.
4Equipment and facility
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the dmg product.
5Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any of its specifications whether or not the batch has been ah-eady distributed.
6Laboratory and QC controls
Laborato1y controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components and diug products confo1m to appropriate standards of identity, strength, quality and purity.
7Laboratory and QC controls
The written stability program for diug products does not include reliable, meaningful, and specific test methods.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diug products purpo1iing to be sterile did not include adequate validation ofthe aseptic and sterilization process.
About this record
Extracted automatically from the document US FDA published on 2026-01-15. 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.
