Description of Event or Problem · 1
AN INVESTIGATION WAS CONDUCTED. A TWO-ANALYST RETEST WAS PERFORMED WITH THE FOLLOWING RESULTS: ANALYST 1: 81.7%, 81.7%, 80.7%, 81.7%, AVERAGE=81.5%, RSD=0.6%. ANALYST 2: 91.4%, 89.7%, 89.7%, 88.3%, AVERAGE=89.9%, RSD=1.4%. THE RETESTING CONFIRMED THAT THE PRODUCT WAS BELOW THE SPEC LIMIT OF 90.0%. THE BATCH RECORDS FOR THIS LOT WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. A REVIEW OF THE RECORDS FOR THE RAW MATERIAL USED IN THIS LOT SHOWED THAT THE MATERIAL MET ALL SPECIFIED REQUIREMENTS. TWO OTHER LOTS OF FINISHED PRODUCT (HEPARIN SODIUM INJECTION, USP, PRODUCT CODE 47101) PRODUCED USING THIS RAW MATERIAL RECEIVER WERE TESTED. IN ADDITION, ALL LOTS OF HEPARIN LOCK FLUSH, NOT CURRENTLY IN THE STABILITY PROGRAM, WERE TESTED. THE FOLLOWING RESULTS WERE OBTAINED: PRODUCT NAME, PRODUCT CODE, LOT #, MFG DATE, ASSAY RESULTS, RESPECTIVELY: HEPARIN SODIUM INJECTION, USP, 4710, 180025, 01/17/98, 100.0%. HEPARIN SODIUM INJECTION, USP, 4710, 180430, 06/08/98, 102.1%. HEPARIN LOCK FLUSH SOLUTION, USP, 1710, 100079, 01/31/00, 102.5%. HEPARIN LOCK FLUSH SOLUTION, USP, 1710, 100495, 07/10/99, 104.3%. HEPARIN LOCK FLUSH SOLUTION, USP, 1710, 180396, 06/01/98, 103.1%. HEPARIN LOCK FLUSH SOLUTION, USP, 1710, 180719, 10/10/98, 101.4%. STABILITY DATA FOR ALL HEPARIN PRODUCT CODES HAVE BEEN TRENDED. NO ADVERSE TRENDS HAVE BEEN IDENTIFIED. A 30-MONTH TEST INTERVAL HAS BEEN ADDED TO ALL EXISTING STABILITY LOTS OF PRODUCT CODE 1710 FOR TRENDING PURPOSES. NO SPECIFIC CAUSE FOR THE FAILING RESULT COULD BE IDENTIFIED. NO CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED. EXPIRATION DATE 36 MOS.