Kensington Medical Holdings LLC

FDA 483 - Kensington Medical Holdings LLC

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Record Details

Kensington Medical Holdings, LLC, a medical device manufacturer in McAllen, TX, was inspected by the FDA from December 5-7, 2022. The inspection revealed 11 observations primarily related to deficiencies in their quality system, including inadequate procedures for complaint investigations, nonconforming product, quality audits, management reviews, supplier evaluations, and various record-keeping and acceptance procedures for their Flash Guard device. The firm also lacked procedures for device recall and training needs.

Company: Kensington Medical Holdings LLC
Product Type: Device
Office: Division of Human and Animal Food Operations - West III
Person: Gilbert Valdez (investigator)

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ID · f903053d-0da8-4544-8073-d10be4073173