483
C-Axis PR., Inc.C-Axis PR., Inc. – FDA 483, Oct 24, 2024
Record Details
An FDA inspection of C-Axis PR., Inc., a contract manufacturer in Caguas, PR, revealed two significant issues. The firm failed to adequately establish procedures for the acceptance of incoming product, specifically regarding sample size for inspection. Additionally, procedures for training and identifying training needs were not adequately established, as evidenced by a lack of documentation for employee training in 2023.
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- San Juan District Office
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ID · 6bf4a6dd-ff32-4636-af56-df6640056d72
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