Command Medical Products LLCNovember 30, 2018

FDA 483 - Command Medical Products LLC - November 30, 2018

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Record Details

Command Medical Products, Inc. in Ormond Beach, FL, received a Form FDA 483 with four observations related to their medical device manufacturing operations. The inspection revealed significant deficiencies in environmental control procedures for clean rooms, corrective and preventive action processes, complaint handling, and supplier control. Several issues were noted as repeat observations from a previous inspection, indicating persistent quality system failures.

Company: Command Medical Products LLC
Inspection Date: November 30, 2018
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Lisa A. Warner (issuing_officer)

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ID · 5b415ecb-a7dc-4a78-a0cd-2360a1b1b460