483
ApiFix, Ltd.FDA 483 - ApiFix, Ltd. - June 11, 2019
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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.
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ID · 85a97c11-c1f4-4eae-82b3-17d5f5158f4a