1Training and personnel
Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
Inspection Record
BSO LLC — FDA 483 Findings
Inspectors Lucila B NwatuThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation ofthe sterilization process.
4Stability and storage
The written stability testing program is not followed.
About this record
Extracted automatically from the document US FDA published on 2024-10-02. 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.
