Inspection Record

Elkhart Pharmacy — FDA 483 Findings

US FDAInspected 2016-01-21Published 2024-01-17 3 findingsContamination controlAseptic processing and sterility assurance

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

Findings

1Contamination control

Protective apparel is not worn as necessary to protect drug products from contamination.

2Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

3Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding systems for maintaining any equipment used.

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.

Elkhart Pharmacy company profile — full history US FDA documents, 2024 Go to Findings search