ARMM IncApril 16, 2019

FDA 483 - ARMM Inc - April 16, 2019

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Record Details

ARMM Inc, a medical device manufacturer in Huntington Beach, CA, was inspected by the FDA. The inspection revealed inadequate documentation for a validated process, specifically concerning sterile barrier integrity for ARMM Drain Catheters. This issue was noted as a repeat observation from a previous inspection.

Company: ARMM Inc
Inspection Date: April 16, 2019
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Juanita Banuelos (investigator)

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ID · 770acc10-7cb3-40f2-acf2-40627d330804