# FDA 483 - Hologic Surgical Products Costa Rica, S.R.L. - September 09, 2024

Source: https://www.keypedia.com/records/483/hologic-surgical-products-costa-rica-srl/f7e9e241-cb92-442f-8071-05e45730d7a0

> FDA 483 for Hologic Surgical Products Costa Rica, S.R.L. on September 09, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hologic Surgical Products Costa Rica, S.R.L.
- Inspection Date: 2024-09-09
- Product Type: device
- Office Name: International Compliance Team
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.keypedia.com/companies/hologic-surgical-products-costa-rica-srl/7cd69227-cc30-4f7f-a7c3-b6282c3d8a9b

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321