1Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
Inspection Record
Walgreens Infusion Services — FDA 483 Findings
Inspectors Jason R. CaballeroThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Written procedures for sanitation are not followed.
3Training and personnel
Production personnel were not practicing good sanitation and health habits.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
5Other quality system
Established sampling plans are not followed and documented at the time of performance.
6Stability and storage
There is no written testing program designed to assess the stability characteristics 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.
