Inspection Record

Coram Healthcare Corporation of Indiana — FDA 483 Findings

US FDAInspected 2017-08-08Published 2024-01-17 4 findingsCleaning validationAseptic processing and sterility assuranceEnvironmental monitoring

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

Findings

1Cleaning validation

Beta-lactam drugs are produced without adequate cleaning procedures to prevent cross contamination.

2Aseptic processing and sterility assurance

Aseptic environmental conditions are are not assured by current monitoring practices.

3Environmental monitoring

The use of sporicidal agents in the cleanroom and/or ISO 5 area is inadequate.

4Aseptic processing and sterility assurance

Equipment, materials, and/or supplies are not disinfected prior to entering the aseptic processing areas.

About this record

Extracted automatically from the document US FDA published on 2024-01-17. 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.

Coram Healthcare Corporation of Indiana company profile — full history US FDA documents, 2024 Go to Findings search