SOL-M

Additional Manufacturer Narrative

BASED ON THE INVESTIGATION PERFORMED, NO ABNORMALITIES WERE IDENTIFIED IN THE BATCH MANUFACTURING RECORDS, RETAINED SAMPLES OR CUSTOMER SAMPLES. THE MOST PROBABLE CONTRIBUTING FACTORS ARE ASSOCIATED WITH ENVIRONMENTAL AND HANDLING CONDITIONS, INCLUDING THE POTENTIAL RELEASE OF FIBERS AND THEIR ADHESION TO PRODUCT SURFACES. IN ADDITION, CONSIDERING THAT THE SYRINGES ARE SUPPLIED STERILE AND EMPTY, AND THAT THE REPORTED CONTAMINATION WAS IDENTIFIED IN FILLED SYRINGES, THE EXACT STAGE AT WHICH THE PARTICULATE MATTER WAS INTRODUCED CANNOT BE DETERMINED WITH CERTAINTY. BOTH MANUFACTURING-RELATED AND POST-MANUFACTURING HANDLING CONDITIONS HAVE BEEN CONSIDERED IN THE EVALUATION. AS SUCH, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED, AND IT CANNOT BE CONCLUDED WHETHER THE OBSERVED MATERIAL ORIGINATED DURING MANUFACTURING OR WAS INTRODUCED DURING SUBSEQUENT HANDLING OR USE. TO FURTHER MITIGATE THE POTENTIAL RISK AND STRENGTHEN PROCESS CONTROLS, THE FOLLOWING REINFORCEMENT ACTIONS HAVE BEEN TAKEN: TRAINING HAS BEEN CONDUCTED FOR ALL RELEVANT PERSONNEL ON PROPER CLEANROOM DRESSING PROCEDURES. REINFORCEMENT OF CLEANROOM GOWNING REQUIREMENTS THROUGH STRICTER SOP ENFORCEMENT, INCLUDING PERSONNEL CHECKS TO ENSURE FULL COMPLIANCE WITH PROTECTIVE CLOTHING REQUIREMENTS. REPLACEMENT OF CURRENT CLEANING CLOTHS WITH CERTIFIED LINT-FREE WIPES FOR ALL EQUIPMENT CLEANING ACTIVITIES WITHIN CONTROLLED ENVIRONMENTS. ADDITIONALLY, NO TRENDS RELATED TO THIS ISSUE HAVE BEEN IDENTIFIED DURING OUR TRACK-AND-TREND ANALYSIS. BASED ON THE DETERMINED RISK PRIORITY NUMBER, THE RESIDUAL RISK RELATED TO THE COMPLAINT IS CONSIDERED ACCEPTABLE.

Description of Event or Problem

CUSTOMER REPORTED THAT DURING THE 100% VISUAL INSPECTION PROCESS, ONE (1) UNIT WAS REJECTED FOR "PARTICULATE/MATERIAL IN THE OTHER CATEGORY, SUSPENDED IN SOLUTION OR ADHERED TO INTERNAL SURFACE OF CONTAINER''. THE PARTICULATE WAS ANALYZED BY THE QC LAB AND DETERMINED TO BE A POLYESTER FIBER BUNDLE.