Precipart CorpFebruary 9, 2018

FDA 483 - Precipart Corp - February 09, 2018

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Record Details

PRECIPART CORPORATION, a contract manufacturer in Farmingdale, NY, was cited for failing to develop written Medical Device Reporting (MDR) procedures. The firm also lacked agreements with its sole medical device customer to define responsibility for MDR reportable events. This indicates a significant gap in their quality system regarding adverse event reporting.

Company: Precipart Corp
Inspection Date: February 9, 2018
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
Person: Ronald Ifraimov (investigator)

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ID · 68d03603-b09b-40ba-86ac-b4479a930d83