# FDA 483 - Kensington Medical Holdings LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/kensington-medical-holdings-llc/f903053d-0da8-4544-8073-d10be4073173

> FDA 483 for Kensington Medical Holdings LLC on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kensington Medical Holdings LLC
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/gilbert-valdez/9226d7ad-71e9-41b0-977e-8de133999b6a)

Company: https://www.globalkeysolutions.net/companies/kensington-medical-holdings-llc/68f07b86-779e-4d99-b8ea-04a65592a7c2

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab