(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: product code from packaging? - confirmed qty (b)(4) = (b)(4) of lot ae2848 and (b)(4) of ae1086.Was product reprocessed? - or is using lights if see thru then they reject.They also place dye (methelyn blue) thru the package.They are random small holes in packaging.
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