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

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.