Inspection Record

PharMerica LLC — FDA 483 Findings

US FDAInspected 2017-04-14Published 2024-01-17 5 findingsAseptic processing and sterility assuranceOther quality systemEnvironmental monitoring

Inspectors Robert M. Barbosa · Sarah E. RhoadesThe inspectors who signed the published document.Inspector lookup

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

Findings

1Aseptic processing and sterility assurance

Personnel were observed touching equipment or other surfaces located outside of the ISO 5 area with gloved hands and then proceeding with aseptic processing without changing or sanitizing gloves.

2Aseptic processing and sterility assurance

Personnel were observed manipulating sterile components outside of the ISO 5 area.

3Other quality system

Surfaces in the classified areas are not disinfected .

4Aseptic processing and sterility assurance

The media fill program does not represent all aseptic activities performed.

5Environmental monitoring

Sporicidal agents are not used in your facility' s cleanrooms and/or ISO 5 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.

PharMerica LLC company profile — full history US FDA documents, 2024 Go to Findings search