1Equipment and facility
Equipment used in the manufacture, processing, packing or holding of diug products is not suitably located to facilitate operations for its intended use.
Inspection Record
Eugia SEZ Private Limited — FDA 483 Findings
Inspectors Ashar P Parikh · Marcellinus D DordunooThe 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
Written records are not always made of investigations into unexplained discrepancies.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of mug products pmpo1i ing to be sterile are not followed.
4Training and personnel
Employees engaged in the manufacture and processing of a dmg product lack the training required to perfo1m their assigned functions.
5Computer system validation
Failure to maintain a backup file of data entered into the computer or related system.
6Process validation
Control procedures are not established which validate the perfo1mance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the diug product.
7Aseptic processing and sterility assurance
Aseptic processing ai·eas ai·e deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
About this record
Extracted automatically from the document US FDA published on 2024-03-15. 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.
