483
Hologic Surgical Products Costa Rica, S.R.L.Hologic Surgical Products Costa Rica, S.R.L. – FDA 483, Sep 9, 2024
Record Details
An FDA inspection of Hologic Surgical Products Costa Rica SRL in El Coyol Alajuela revealed two significant observations. The firm failed to ensure Device History Records accurately reflect manufacturing processes and did not adequately establish procedures for receiving, reviewing, and evaluating complaints, including trending and investigation. These issues indicate deficiencies in the firm's quality system for medical device manufacturing.
- Inspection date
- September 9, 2024
- Product type
- device
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ID · f7e9e241-cb92-442f-8071-05e45730d7a0
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