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Medical Devices / Inspections and Audits

Sarstedt Dinged for Inadequate Documentation

Feb. 26, 2019
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The FDA rapped Newton, North Carolina devicemaker Sarstedt after a June 28 to July 2, 2018 inspection revealed deficiencies in its document change and labeling procedures.

The company’s device master record change approval forms for box art updates to the S-Monovette, a blood collection system, failed to list revisions or a control number for various updates.

In addition, the agency found the facility didn’t ensure that all labels and labeling used for each production batch were documented in the device history record.

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