1Aseptic processing and sterility assurance
Separate or defined ai·eas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of diu g products.
Inspection Record
Brassica Pharma Pvt Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
3Equipment and facility
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drng product.
4Process validation
Written production and process control procedures are not followed in the execution ofproduction and process control functions and documented at the time of perfo1mance.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diu g products pmpo1ting to be sterile are not established, written and followed.
6Contamination control
Protective apparel is not worn as necessru.y to protect diug products from contamination.
7Other quality system
Laborato1y records do not include complete data derived from all tests, examinations and assay necessa1y to assure compliance with established specifications and standards.
8Laboratory and QC controls
Laborato1y controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that diug products confo1m to appropriate standards of identity, strength, quality and purity.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diug products pmpo1iing to be sterile did not include adequate validation of the aseptic and sterilization process.
About this record
Extracted automatically from the document US FDA published on 2024-07-25. 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.
