Lantheus Medical Imaging, Inc.
Form 483 issued April 9, 2026
- Inspection
- Mar 9 – Apr 9, 2026
- Investigators
- Daniel L. Zheng· Lori M. Newman
- Observations
- 7
- Pages
- 11
- FEI number
- 1216602
In short: On April 9, 2026, FDA issued a Form 483 with 7 observations to Lantheus Medical Imaging, Inc. (FEI 1216602) after an inspection that ran Mar 9 – Apr 9, 2026. The investigators were Daniel L. Zheng and Lori M. Newman. Most observations concern quality system and packaging & labeling.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
The responsibilities and procedures applicable to the quality control unit are not in writing and fully…
- 03
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
This inspection in context
Daniel L. Zheng
24 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmLantheus Medical Imaging, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lantheus Medical Imaging, Inc.?
FDA listed 7 observations on this Form 483, mostly about quality system, packaging & labeling and materials. The opening words of each observation are shown on this page.
Who inspected Lantheus Medical Imaging, Inc.?
Daniel L. Zheng and Lori M. Newman are named on this Form 483, for the inspection of Mar 9 – Apr 9, 2026. Each investigator has a profile showing what they cite most.
When was Lantheus Medical Imaging, Inc. inspected by FDA?
The inspection ran Mar 9 – Apr 9, 2026, and the Form 483 is dated April 9, 2026.
How do I get the full Form 483 for Lantheus Medical Imaging, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.