(b)(4).Batch record review: lot 0a00693 was manufactured on 01/07/2020, in uhlman #2 line, with a total of (b)(4) market units.Compliance engineer id 6054 performed a batch record review on 03/22/2021, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom and all the tooling information documented was also correct, under icc code 187662 sap material id 1704763.The batch record review supports that there were no discrepancies related to the issue reported.Photograph, video and/or physical sample evaluation: there are photographs associated with this case and in these, the reported defect can be seen.No unused return sample was expected.Conclusion summary of the related event: based on the investigation findings, the following root causes were found per line and failure mode reported: doyen b line, dressing caught in seal: method, dressing not into infeed conveyor pitch: it was detected that the pick and place tooling were required to be refurbished since the dressings were not falling into the infeed conveyor pitch, causing a delay in the advancement of the dressing in relation to the sealing process.Method, manual setting of indexation process during changeover: it was determined that the manufacturing personnel must adjust the index parameters related to the dressing and the cutter station.These parameters are adjusted visually, with no documented reference, once the product is out of the machine.There is not a stablished method on how to perform this task.Method, tensor of material positioning: the required tension is given by the crank position of the spindle where the film is placed just before the entrance of the dressings to the sealing station.The incorrect set of tension could cause dressing caught in seal because it could interrupt the dressing flow from the infeed conveyor to the paper index, dressing could be misplaced by the delay.There is no visual help not a standard step by step on how to perform this task.Machine, incorrect dressing tooling on machine: it was detected that not all tooling was properly labeled.It was demonstrated that the incorrect tooling on the sealing station, pick and place and/or infeed conveyor can lead to the failure mode dressing caught in seal because the dressing related to the film/paper can be misaligned and therefore over the sealing print.Uhlmann #2 line, dressing caught in seal: method, lack of visual help for manual dressing placement: dressings can be placed either manually or automatically with a pick and place tooling, according to the dressing size.It was determined that there is a job aid (pi31-116 ja4, ver.1.0) related to the setting of the pick and place per type of product, but there is not a stablish job aid with images for the manual dressing placement.If the dressing is not placed accordingly on the blister preformed cavity, then the defect dressing caught in seal appears.Machine, suction cup worn out from pick and place: pick and place tooling could fail if the suction cups are worn out.Uhlmann #2 line, packaging torn/crushed: material, film/paper with holes and fold/creases: for the film impacted it was perceived that it does not have a uniform coloring.It was demonstrated that the aspect of ¿wrinkles¿ on the product when using the decoloured film.Therefore, it is required to raise a notification to the film supplier in order to improve the manufacturing process of it and avoid a poor visual appearance on the final product.On the other hand, paper material presented no scars nor problems during manufacturing process.No holes nor wrinkles were perceived.Machine, loose push tooling from the machine arm: it was demonstrated that if the push tooling of the cartoner machine arm is loose, it does not stay parallel to the blister border during operation, instead it creates and angle related to the blister border, causing the blister packs not to enter completely inside the preformed mku.As a result, the cartoner will try to close the mku damaging the blister that were not completely inside of it.Machine, position of sensor to detect blister out of the box: on the cartoner machine, there is a sensor that detects if a blister is not completely inside the mku.If a blister is not completely inside de mku then the sensor detects it and stops the machine prior to start the next stage of the process which is closing the flaps of the carton, that could lead into a damaged blister.It was demonstrated that if the sensor is not on the right position it will not detect the blister.The sensor is over a base that gets loose over time.Machine, flap carton tooling too rigid: closure of the flap carton is the next process step on the cartoner machine after inserting the blister onto the mku.It was detected that the tooling of the flap carton is too rigid, so if a blister is not completely inside the mku it could be damaged if the cartoner tries to close the flap of the carton.The capa plan tw#1439285 was generated for mitigate the root causes identified.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.
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