1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of mug products pmpo1ting to be sterile did not include adequate validation of the aseptic process.
Inspection Record
Eugia Pharma Specialities Limited — FDA 483 Findings
Inspectors Justin A Boyd · Eileen A Liu · Anastasia M ShieldsThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Your fnm failed to establish adequate written procedures for production and process controls designed to assure that the diug products have the identity, strength, purity, and quality that they are purported or represented to possess.
3Other 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.
4Other quality system
Changes to written procedures are unit.
5Documentation and records
Batch production and control records do not include complete info1mation relating to the production and control of each batch.
6Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
7Laboratory and QC controls
Laborato1y conti·ols 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.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of mug products pmpo1ting to be sterile are not established and followed.
9Deviation, 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 of its specifications whether or not the batch has been ah-eady distributed.
About this record
Extracted automatically from the document US FDA published on 2024-02-13. 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.
