# FDA 483 - Hummingbird Med Devices, Inc. - August 26, 2019

Source: https://www.keypedia.com/records/483/hummingbird-med-devices-inc/e3fd75ba-f89b-4ce7-a8fe-d0a35a0e6e30

> FDA 483 for Hummingbird Med Devices, Inc. on August 26, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hummingbird Med Devices, Inc.
- Inspection Date: 2019-08-26
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Hummingbird Med Devices, Inc., a manufacturer of the Hummi Micro-Draw blood collection system in Camano Island, WA, received two observations during an FDA inspection. The firm's procedures for corrective and preventive actions were found to be inadequately established, with CAPA files lacking complete documentation. Additionally, procedures for ensuring purchased products and services conform to requirements were insufficient, specifically regarding supplier qualification and verification of FDA registration.

## Related Officers

- [Stephen R. Souza](https://www.keypedia.com/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.keypedia.com/companies/hummingbird-med-devices-inc/5b471ed7-ad89-4825-971c-ba9d43a0401a

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822