![]() ![]() All DHRs were reviewed and approved.įor more information on device history records and the differences between DHF (design history file), DMR (device master records) and DHR (device history record) see FDA presentation, Documents, Change Control and Records and the transcripts to the presentation. These deficiencies were not identified as nonconformances. DHR for … lot … did not include data summarizing QA test results for product QA release. DHR for… lot … did not include data for all QA tests performed during the product QA release process.ĭ. DHR for … lot … did not include a … QA Solution Preparation form.Ĭ. ![]() DHR for … lot … noted the amount of … added to the … solution as … however, this amount does not match the amount of … specified in the product’s formulation.ī. A device history record has not been adequately maintained.Ī.
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