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
Eugia Pharma Specialities Limited — FDA 483 Findings
Inspectors Anastasia M Shields · Justin A Boyd · Vaishali J PatelThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of chug products pmpo1iing to be sterile did not include adequate validation of the aseptic process.
3Contamination control
Separate or defmed areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
4Other quality system
Your fnm failed to establish adequate written procedures for production and process conti·ols designed to assure that the diug products have the identity, strength, purity, and quality that they are purported or represented to possess.
5Deviation, 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.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of mu g products pmpo1ting to be sterile are not established and followed.
About this record
Extracted automatically from the document US FDA published on 2024-05-13. 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.
