# FDA 483 - Hologic, Inc - September 24, 2024

Source: https://www.globalkeysolutions.net/records/483/hologic-inc/fa6144b2-7c16-4278-acbe-204d6d2ddc0a

> FDA 483 for Hologic, Inc on September 24, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hologic, Inc
- Inspection Date: 2024-09-24
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Hologic, Inc. in Marlborough, MA, revealed significant deficiencies in the design controls, corrective and preventive actions, and medical device reporting for their BioZorb implantable radiographic marker and its accessory device. The firm failed to adequately establish design inputs, conduct complete verification and validation testing, properly manage complaints, and report adverse events and field actions, indicating systemic quality system failures that could impact patient safety.

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## 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