Inspection Record

Isorx, Corp. — FDA 483 Findings

US FDAInspected 2019-09-18Published 2019-11-12 3 findingsAseptic processing and sterility assuranceDocumentation and records

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

Findings

1Aseptic processing and sterility assurance

Sporicidal agents were not used in your facility's cleanrooms and/or ISO 5 classified aseptic processing area.

2Documentation and records

Batch production and control records are not prepared for each batch of drug product produced and do not include complete information relating to the production and control of each batch.

3Aseptic processing and sterility assurance

Disinfocting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.

About this record

Extracted automatically from the document US FDA published on 2019-11-12. 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.

Isorx, Corp. company profile — full history US FDA documents, 2019 Go to Findings search