Pharma Tech Solutions, IncJanuary 15, 2020

FDA 483 - Pharma Tech Solutions, Inc - January 15, 2020

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Record Details

Pharma Tech Solutions, Inc., a medical device manufacturer in Westlake Village, CA, was inspected by the FDA. The inspection revealed a significant issue related to the documentation of design review results in the design history file. This indicates a deficiency in their quality system for medical device design control.

Company: Pharma Tech Solutions, Inc
Inspection Date: January 15, 2020
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Sarah A. Hassas (investigator)

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ID · 103388bf-3d33-470e-8f32-8d57085423a8