FDA 483 - Kensington Medical Holdings LLC

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.