H.6.Investigation: material 245122 is manufactured by rehydrating the media components with usp purified water, and thoroughly mixing until a homogeneous solution is obtained.The tubes are filled, capped, torqued, and then labeled by machine per standard operating procedure (sop).The tubes are terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, tubes are packaged into final shipping configurations.The batch history record review for batch 1063895 was satisfactory per internal procedures.Filling, labeling and packaging processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and three other complaints have been taken on this batch for labeling.Retention samples from batch 1063895 (100 tubes) were available for inspection.No labeling defects were observed in 100/100 retention samples.All retention tubes had one tube label that had legible batch information and a scannable barcode.No photos were received to assist with the investigation.No returns were received to assist with the investigation.This complaint cannot be confirmed.Bd will continue to trend complaints for labeling.
|