SOL-MILLENNIUM

Description of Event or Problem

"CUSTOMER REPORTED: WE RECEIVED A COMPLAINT FROM RIVM FOR ITEM P180001PP WITH BATCH 04105025. IT HAD SEVERAL DEFECTS: SYRINGE WITHOUT GRADUATION MARKS: 1 PIECE. SYRINGE WITHOUT PLUNGER: 1 PIECE. CLOSED PACKAGING WITHOUT SYRINGE: 1 PIECE. SYRINGE EXPANDED AND WITH FISSURES; FRACTURE CRACKS: 3 PIECES."

Additional Manufacturer Narrative

THERE IS NO EVIDENCE OF QUALITY ISSUES ASSOCIATED WITH THIS COMPLAINT BASED ON THE ARCHIVE SAMPLE ANALYSIS. BASED ON THE DETERMINED RISK PRIORITY NUMBER, THE RESIDUAL RISK RELATED TO THE COMPLAINT IS CONSIDERED ACCEPTABLE. SOL MILLENNIUM CONTINUES TO MONITOR THIS KIND OF ISSUE. ADDITIONAL ASSESSMENT WILL BE TAKEN IF A SIGNIFICANT PATTERN EMERGES. UNCONFIRMED. THIS REPORT WAS INITIALLY SUBMITTED ON 04/08/2024. DUE TO ISSUES WITH DISPLAYING THE INITIAL SUBMISSION, THIS SUBMISSION CONTAINS BOTH INITIAL AND SUPPLEMENTAL INFORMATION.

Additional Manufacturer Narrative

THIS REPORT WHEN INITIALLY SUBMITTED ENCOUNTERED AN INTERNAL ISSUE POTENTIALLY RELATED TO DATABASE CONNECTIVITY. THIS ISSUE WAS IDENTIFIED WHILE IMPLEMENTING CAPA-57 WHICH WAS OPENED FOLLOWING AN FDA INSPECTION.