This retrospective mdr is filed as a correction to an audit conducted 06-jun-2017 by a former fda investigator (consultant).We observed the packaging deformations.This product's sterile barrier packages are produced on a multivac form-fill-seal machine.The root cause was found to be unoptimized process parameters with the multivac.We subjected 31 syringes returned by the customer to performance testing.The tests included peel strength, dye penetration, and seal quality (visual).All product inspected passed performance tests.(b)(4) samples were evaluated, and all packaging was sealed.The samples contained deformations on or near seals that was not desirable.Production final inspection includes a visual check of all product.A review of the device history record showed that samples met in process performance testing and final inspection acceptance criteria.A review of corrective actions taken since the manufacture of these lots of product (nov.2015) revealed that minor equipment adjustments to the multivac were implemented and completed validation in (b)(4) 2016.We reviewed historical complaint files since the improvements to the packaging and it shows no further complaints of this nature ytd (jul-2017).
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