1Stability and storage
Labeling for Colistimethate Sodium for Inhalation, USP indicates Keep Refrigerated (2- 8°C) storage requirements.
Inspection Record
IV Solutions of Lubbock — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The above referenced product is not tested for potency ofthe active ingredient.
3Aseptic processing and sterility assurance
The phannacy is currently assigning a ninety day expiration date for the product based on contract lab sterility test results on the "test batch".
4Aseptic processing and sterility assurance
The product is not routinely or periodically tested for sterility to demonstrate process control and the consistent ability to perform aseptic fill operations.
5Complaint and recall handling
Not all patient complaints are documented in a complaint log and/or investigated per requirements specified in Policy number PP-18, Title: Patient Grievance Procedures.
6Aseptic processing and sterility assurance
Activities and movement with-in the sterile products preparation room is directed by Policy # PP 21, Title: Sterile Products Preparation Room.
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.
