# NuPak Medical, Ltd – FDA 483, Feb 25, 2022

Source: https://www.keypedia.com/records/483/nupak-medical-ltd/c2f91051-4c92-41fc-a80b-a35595ad412f

> FDA 483 for NuPak Medical, Ltd on February 25, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NuPak Medical, Ltd
- Inspection Date: 2022-02-25
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of NuPak Medical in San Antonio, Texas, a device manufacturer, revealed two observations related to the firm's quality system. The company failed to implement its procedures for corrective and preventive actions (CAPA) and did not process customer complaints in a uniform and timely manner as required by its own established procedures. These issues indicate a breakdown in the firm's adherence to its internal quality management processes.

## Related Officers

- [Jennifer Cunningham](https://www.keypedia.com/people/jennifer-cunningham/5c332d60-b1e8-444f-8994-68cb1586c7eb)

Company: https://www.keypedia.com/companies/nupak-medical-ltd/5f4aca0d-a662-411e-bfd1-3797d63c1115

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