Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-04.
At a glance
Inspections
8
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Apr 2026 – 4 May 2026 | Human Drugs | 483 | View 483 → |
| 28 Jul 2025 – 1 Aug 2025 | Biologics | 483 | View 483 → |
| 7 Jan 2019 – 15 Jan 2019 | Human Drugs | 483 | View 483 → |
| 7 May 2014 – 9 May 2014 | Human Drugs | Clean | |
| 10 Nov 2011 | Not recorded | 483 | View 483 → |
| 27 May 2010 | Not recorded | 483 | View 483 → |
| 31 Jan 2008 | Not recorded | Clean | |
| 5 Apr 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Ramon E Martinez2 insp.
Sean R Marcsisin1 insp.
Laurel A Beer1 insp.
John P Mistler1 insp.
Stacey S Degarmo1 insp.
Matthew D Silverman1 insp.
Rory Geyer1 insp.
Richard H Penta1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Element Materials Technology Boston - Acton 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