Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-23.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Feb 2026 – 23 Feb 2026 | Human Drugs | Clean | |
| 5 Sep 2022 – 9 Sep 2022 | Human Drugs | 483 | View 483 → |
| 24 Oct 2018 – 30 Oct 2018 | Human Drugs | Clean | |
| 19 Mar 2018 – 22 Mar 2018 | Human Drugs | 483 | View 483 → |
| 22 Jun 2016 – 28 Jun 2016 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Sep 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Alan M Barker, Joseph A Piechocki
9 Sep 2022
21 CFR 211.68(b)
Computer control of master formula records
Cited by Alan M Barker, Joseph A Piechocki
Investigators
FDA investigators tied to this site in the record.
Emily J Orban2 insp.
Nicholas J Presto1 insp.
Alan M Barker1 insp.
Joseph A Piechocki1 insp.
Emilie Kahn1 insp.
Tina M Pawlowski1 insp.
Aurora-Miha Trifanov1 insp.
Shirshendu K Deb1 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 | 3x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Element Materials Technology Ann Arbor, LLC's 2 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