1Equipment and facility
Cleaning of production and processing areas, equipment and utensils used for the production of highly potent and beta-lactam containing drugs is inadequate to prevent potential cross-contamination.
Inspection Record
Shiraz Specialty Pharmacy Inc. dba Axis Pharmacy Northwest — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment and tools used are not of appropriate materials for use in drug production.
3Material and supplier control
Non-pharmaceutical grade components are used in the production of non-sterile drug products.
4Material and supplier control
Drug components used in the production of highly potent, hazardous and non-hazardous drug products are not adequately stored.
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.
