Inspection Record

Eugia Steriles Private Limited — FDA 483 Findings

US FDAInspected 2024-04-05Published 2024-04-16 3 findingsProcess validationAseptic processing and sterility assuranceOther quality system

Inspectors Teresa I NavasThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Process 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.

2Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of mug products pmpo1ting to be sterile are not established and followed.

3Other quality system

Input to and output from the computer and records or data are not checked for accuracy.

About this record

Extracted automatically from the document US FDA published on 2024-04-16. 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.

Eugia Steriles Private Limited company profile — full history US FDA documents, 2024 Go to Findings search