# FDA 483 - Lantheus Medical Imaging, Inc. - April 09, 2026

Source: https://www.keypedia.com/records/483/lantheus-medical-imaging-inc/16ac8a8e-d900-4971-8a0b-df55a8e30070

> FDA 483 for Lantheus Medical Imaging, Inc. on April 09, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lantheus Medical Imaging, Inc.
- Inspection Date: 2026-04-09
- Product Type: drugs
- Office Name: New England District Office
- Summary: Lantheus Medical Imaging, Inc. in North Billerica, MA, was cited for significant deficiencies across its manufacturing and quality control operations. The inspection revealed failures in thoroughly investigating batch failures, particularly concerning high visual inspection defect rates, and inadequate quality control unit procedures, including oversight of contract manufacturers and employee training. Additionally, the firm lacked scientific justification for component sampling, had deficient laboratory controls, and failed to maintain strict control over labeling materials and computer systems.

## Related Officers

- [M.S., Consumer Safety Officer at FDA](https://www.keypedia.com/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)
- [Deputy Director](https://www.keypedia.com/people/lori-m-newman/a0e448e4-11ba-4095-b879-feabb8750b3f)

Company: https://www.keypedia.com/companies/lantheus-medical-imaging-inc/6e9954f9-4df0-41b8-bad7-e8117a91ef76

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