1Other quality system
Non-depyrogenated containers were used in drug production.
Inspection Record
Wells Pharmacy Network LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Buildings used in the processing of a drug products are not maintained in a good state of repair.
3Environmental monitoring
The use of the sporicidal agent in the cleanrooms is inadequate.
4Contamination control
Procedures designed to prevent microbiological contamination of drug products are not established, written, and followed.
5Aseptic processing and sterility assurance
Your firm failed to conduct smoke studies under dynamic conditions.
6Equipment and facility
The flow of drug products through the building is not designed to prevent contamination.
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.
