Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-11-08.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Oct 2022 – 8 Nov 2022 | Human Drugs | 483 | View 483 → |
| 15 Sep 2019 – 23 Sep 2019 | Human Drugs | 483 | View 483 → |
| 31 Oct 2016 – 7 Nov 2016 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Nov 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Jacob G Lutz, Gavin T Cua
23 Sep 2019
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Rachael A Moliver, Michael E Maselli
23 Sep 2019
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Rachael A Moliver, Michael E Maselli
23 Sep 2019
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Rachael A Moliver, Michael E Maselli
7 Nov 2016
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Laurimer Kuilan-Torres, Vilmary Negron Rodriguez
Investigators
FDA investigators tied to this site in the record.
Jacob G Lutz1 insp.
Gavin T Cua1 insp.
Rachael A Moliver1 insp.
Michael E Maselli1 insp.
Laurimer Kuilan-Torres1 insp.
Vilmary Negron Rodriguez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Isotopia Molecular Imaging's 3 Form 483s
Source PDFs 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