Identipak Inc

FDA 483 - Identipak Inc

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Identipak Inc, a medical device manufacturer in McAllen, TX, received a Form FDA 483 citing two significant quality system deficiencies. The firm lacked established procedures for the rework and reevaluation of nonconforming medical devices. Additionally, Identipak Inc failed to document the evaluation of its suppliers for incoming materials.

Company: Identipak Inc
Product Type: Device
Office: Division of Human and Animal Food Operations - West III
Person: Amber Smith

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ID · 5929c641-f14c-4af5-a0cf-7caffacec2db