# FDA 483 - Hologic, Inc - November 04, 2025

Source: https://www.globalkeysolutions.net/records/483/hologic-inc/9cc10e5f-ee82-47a6-8bb9-af4ecec7b2c0

> FDA 483 for Hologic, Inc on November 04, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hologic, Inc
- Inspection Date: 2025-11-04
- Product Type: device
- Office Name: New England District Office
- Summary: Hologic, Inc. in Marlborough, MA, received a Form FDA 483 following an inspection of its medical device facility. The inspection revealed significant deficiencies in corrective and preventive action procedures, complaint handling, and management review processes, particularly concerning risk assessments for breast biopsy systems. These issues, including repeat observations from a previous inspection, indicate a lack of adequate controls to ensure device safety and quality.

## Related Documents

- [483 - 2024-09-24](https://www.globalkeysolutions.net/records/483/hologic-inc/fa6144b2-7c16-4278-acbe-204d6d2ddc0a)

## Related Officers

- [Power Trader/Data Scientist](https://www.globalkeysolutions.net/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.globalkeysolutions.net/companies/hologic-inc/4d48f318-a95f-441e-9118-6ce684212e08

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144