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Medical devices.

Publication: Warning Letter Bulletin
Publication Date: 16-JUN-03
Format: Online
Delivery: Immediate Online Access

Article Excerpt
12481W

Lake Charles Memorial Hospital, Lake Charles, LA, May 27 (CDRH). Dana Daigle, an investigator from FDA's New Orleans District Office, inspected the firm's Institutional Review Board (IRB) Feb. 4-6. The audit revealed that the IRB did not conduct continuing reviews of studies, adverse events and safety reports to...

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