Overview
- 12 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-09.
At a glance
Inspections
12
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Mar 2026 – 9 Apr 2026 | Human Drugs | 483 | On file |
| 19 Dec 2023 – 21 Dec 2023 | Human Drugs | Clean | |
| 13 Dec 2021 – 6 Jan 2022 | Human Drugs | Clean | |
| 8 Jan 2018 – 19 Jan 2018 | Human Drugs | Clean | |
| 17 May 2016 – 24 May 2016 | Human Drugs | Clean | |
| 24 Feb 2015 – 5 Mar 2015 | Human Drugs | 483 | View 483 → |
| 10 Jun 2013 – 20 Jun 2013 | Human Drugs | 483 | View 483 → |
| 18 Jul 2011 | Not recorded | 483 | View 483 → |
| 9 Jul 2009 | Not recorded | 483 | On file |
| 1 Jul 2009 | Not recorded | Clean | |
| 19 Apr 2007 | Not recorded | Clean | |
| 24 Jun 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Mar 2015
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Edmund F Mrak, Carlos Chavez, Richard B Mcaroy
5 Mar 2015
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Edmund F Mrak, Carlos Chavez, Richard B Mcaroy
5 Mar 2015
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Edmund F Mrak, Carlos Chavez, Richard B Mcaroy
Investigators
FDA investigators tied to this site in the record.
Robert J Martin3 insp.
Stacey S Degarmo3 insp.
Lori M Newman2 insp.
Edmund F Mrak2 insp.
Debra M Emerson2 insp.
Leo B Zadecky2 insp.
Daniel L Zheng1 insp.
Matthew C Watson1 insp.
Meredith L Miller1 insp.
John P Mistler1 insp.
Carlos Chavez1 insp.
Richard B Mcaroy1 insp.
Rory Geyer1 insp.
Amy C Jordan1 insp.
Justine M Corson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lantheus Medical Imaging, Inc.'s 5 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat