A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.Our records show that the supplied drugs components continue to meet potency specifications.Complaint history review does not indicate any trends for the drug lot numbers reported in this complaint.There was no sample that was returned for investigation, therefore, the reported complaint could not be confirmed or duplicated.No root cause could be determined since the complaint could not be confirmed since no samples or pictures were received for evaluation.No 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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