Description of Event or Problem · 1
THIS ITEM DOESN'T MEET THE SPECS FOR FACILITY'S LAB AND IS NOT EQUIVALENT TO THOSE IN FEDLOG. INVESTIGATION FINDINGS: SUBJECT ITEM WAS NOT PROCURED BY THE DEPOT SYS BUT PER THE CENTRALIZED SYS. A REVIEW OF THE SPEC INDICATES THE DIMENSIONS ARE 75 MILLIMETERS LENGTH AND 25 MILLIMETERS WIDTH [WITH A + / -(PLUS/MINUS) TOLERANCE OF 0.8 MILLIMETERS FOR EACH DIMENSION]. THE THICKNESS RANGE IS 0.8 TO 1.1 MILLIMETERS. A REVIEW OF THE FEDERAL LOGISTICS CATALOG FOUND: OVERALL THICKNESS RANGE 0.8 MILLIMETERS MINIMUM AND 1.1 MILLIMETERS MAXIMUM WAS CORRECTLY LISTED; THE DIMENSIONS FOR OVERALL LENGTH AND OVERALL WIDTH SHOULD BE LISTED AS: OVERALL LENGTH 75.0 MILLIMETERS (MINIMUM 74.2 MILLIMETERS AND MAXIUM 75.8 MILLIMETERS), AND OVERALL WIDTH 25.0 MILLIMETERS (MINIMUM 24.2 MILLIMETERS AND MAXIMUM 25.8 MILLIMETERS). INSTEAD OF LISTED AS: OVERALL LENGTH 75.4 MILLIMETERS NOMINAL, OVERALL WIDTH 25.0 MILLIMETERS NOMINAL. SOMEONE MAY HAVE BEEN PROVIDED THE WRONG ITEM IF THE ITEM REC'D WAS NOT IN ACCORDANCE WITHIN THE DIMENSIONS AS INDICATED IN THE SPEC. FACILITY IS CONSIDERING SUBJECT COMPLAINT AN ISOLATED INCIDENT. FACILITY HAS REC'D NO OTHER QUALITY COMPLAINTS ON SUBJECT FIRM. THE COMPLAINT HAS BEEN ADDED TO FACILITY'S QUALITY HISTORY DATA FILE. FACILITY WILL MONITOR SUBJECT FIRM AND IF SIMILAR COMPLAINTS ARE REC'D FACILITY WILL INITIATE AN INVESTIGATION. ACTION TAKEN TO CORRECT EXISTING DEFICIENCY: AN INFORMATIONAL COPY OF THE COMPLAINT WAS FORWARDED TO THE FIRM. ACTION TAKEN TO PRECLUDE RECURRENCE: THE FDA WAS PROVIDED AN INFORMATIONAL COPY OF THE COMPLAINT. DISPOSITION INSTRUCTIONS: TO BE LOCALLY DETERMINED. (RETAIN MATERIAL UNTIL ADVISED. NEED FOR ALERT NOTIFICATION: NOT APPLICABLE.