Telephone number: (b)(6).Eighteen samples were received for sample evaluation.A visual inspection revealed that twelve units had solvent smudges on the bag ports, two samples had cloudiness at the white injection site connection (excessive solvent), three samples had a very tiny black spot on the bag, and one sample had a particle inside the pouch under the tpn bag.The black spots on bags were embedded in the bag material as they did not move even when rubbed from both outside and inside of bag.The particle in the pouch seemed to be a glue particle most probable from the pouch sealing machine.There was no evidence of cuts or grazes on/inside the tubing of the middle additive port.Therefore, the reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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