# FDA 483 - Hologic, Inc. - October 14, 2022

Source: https://www.keypedia.com/records/483/hologic-inc/96822c88-d306-4206-80f0-0737b110bd2e

> FDA 483 for Hologic, Inc. on October 14, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hologic, Inc.
- Inspection Date: 2022-10-14
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Hologic, Inc. in San Diego, CA, a medical device manufacturer, was cited for significant quality system deficiencies during an FDA inspection. Observations included failure to submit a Medical Device Report for a serious injury, inadequate complaint investigations, unapproved design changes, and insufficient design validation and stability testing for their Rapid fFN TLiIQ System. These issues indicate a lack of robust control over critical manufacturing and post-market surveillance processes.

## Related Officers

- [Jenny L Mccardell](https://www.keypedia.com/people/jenny-l-mccardell/b8fa04db-6acc-48d1-b0be-56777704ae51)
- [James R. Montero](https://www.keypedia.com/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.keypedia.com/companies/hologic-inc/e60542f3-3b14-4264-802f-9828d3aaf5e1

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6