Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-22.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 May 2026 – 22 May 2026 | Human Drugs | 483 | On file |
| 31 Aug 2020 – 9 Dec 2020 | Human Drugs | 483 | View 483 → |
| 16 Oct 2017 – 7 Nov 2017 | Human Drugs | 483 | On file |
| 12 Apr 2017 – 1 May 2017 | Human Drugs | 483 | On file |
| 16 Dec 2014 – 7 Jan 2015 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Sean R Marcsisin2 insp.
Erik W Koester1 insp.
Robert J Martin1 insp.
John P Mistler1 insp.
Mary-Jeanet Mcgarry1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.20(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.40(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cambridge Isotope Laboratories, Inc.'s 5 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