Inspection Record

Walgreens Home Care, Inc. dba Walgreens Infusion Services — FDA 483 Findings

US FDAInspected 2015-08-18Published 2024-01-17 6 findingsEquipment and facilityStability and storageContamination controlAseptic processing and sterility assurance

Inspectors Jason R Caballero · Lisa R JenningsThe inspectors who signed the published document.Inspector lookup

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

Findings

1Equipment and facility

Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds , insects, and other vermin.

2Stability and storage

There is no written testing program designed to assess the stability characteristics of drug products.

3Contamination control

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

4Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.

5Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

6Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be steri le are not followed.

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.

Walgreens Home Care, Inc. dba Walgreens Infusion Services company profile — full history US FDA documents, 2024 Go to Findings search