ApiFix, Ltd.June 11, 2019

FDA 483 - ApiFix, Ltd. - June 11, 2019

Record Details

ApiFix, Ltd. in Holon, Israel, was inspected by the FDA, revealing two significant observations. The inspection found deficiencies in process validation, specifically regarding undefined acceptance criteria for seal strength and bubble leak tests, and inadequately established operating parameters for a machine. Additionally, the firm lacked adequately established procedures for controlling environmental conditions.

Company: ApiFix, Ltd.
Inspection Date: June 11, 2019
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Maida Hrenesan
Mary A. Millner

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ID · 85a97c11-c1f4-4eae-82b3-17d5f5158f4a