Inspection Record

Home Infusions Solutions, Inc. — FDA 483 Findings

US FDAInspected 2015-07-10Published 2024-01-17 5 findingsContamination controlAseptic processing and sterility assuranceEquipment and facilityStability and storage

Inspectors Anita R. MichaelThe inspectors who signed the published document.Inspector lookup

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Findings

1Contamination control

The control systems necessary to prevent contamination or mix-ups are defi cient.

2Aseptic processing and sterility assurance

Procedures designed toprevent microbiological contamiriation ofdrugproducts purporting to be sterile are not established.

3Contamination control

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

4Equipment and facility

Buildings used in the manufacture, processing, packing.

5Stability and storage

There is no written testing program designed to assess the stability cbaract..,"'istics of drug products.

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.

Home Infusions Solutions, Inc. company profile — full history US FDA documents, 2024 Go to Findings search