No device was returned.The following operations were reviewed, in order to verify that the operations were properly performed, also records were reviewed, in order to ensure that complied with gmp (good manufacturing practices) requirements and procedures: the assemble base with cannula to inserter operation was reviewed to ensure that the cannula is properly assembled; no discrepancies were found.The operators that perform critical operations such as bond skin adhesive film onto flange of sleeve and the skin adhesive inspections using a monitor are certified.The operator performs the visual inspection of the adhesive using the skin adhesive inspection.Visual inspection of thirty-two samples from a different lot number were taken from production line and were visually inspected in order to verify that the spring is not released.No discrepancies were detected.Four samples from the same lot number were taken from production floor and tested for in-process testing and no discrepancies were found.Results: no discrepancies were detected.The retractor assemblies were 100 percent visually inspected by the production personnel to assure that the needle is properly threaded.Production personnel verified 100 percent that parts were not damaged (including scratches) or distorted/warped.Quality personnel verifies 100 percent that the needle tip is up, and the blunt end is fully seated and verify the length while still in the needle hub on the pallet.No root cause could be determined, as no samples or pictures were received for evaluation.No corrective actions are required since the complaint could not be confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
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