FDA Cites Single-Use Reprocessor For 17 QS/GMP Violations
This article was originally published in The Gray Sheet
Executive Summary
Visions in Endosurgery, Inc.' s "failure to develop, conduct, control, and monitor production processes involving the reprocessing of single-use and reusable devices" is cited by FDA in a Jan. 6 warning letter to the Port Orange, Florida reprocessing facility.
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