Overview
- 10 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-28.
At a glance
Inspections
10
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 May 2026 – 28 May 2026 | Foods & Cosmetics | 483 | On file |
| 1 Jul 2025 | Foods & Cosmetics | Clean | |
| 19 Mar 2024 – 21 Mar 2024 | Foods & Cosmetics | Clean | |
| 13 Sep 2022 – 15 Sep 2022 | Foods & Cosmetics | 483 | View 483 → |
| 25 May 2018 | Foods & Cosmetics | 483 | On file |
| 22 Apr 2015 | Foods & Cosmetics | 483 | On file |
| 23 May 2014 | Foods & Cosmetics | Clean | |
| 13 Jul 2011 | Not recorded | 483 | On file |
| 20 Apr 2010 | Not recorded | 483 | View 483 → |
| 21 Jul 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Sep 2022
21 CFR 80.37
Treatment of batch pending certification
Cited by Bhakti Petigara Harp, Kimberlee A Ewing, Bryan K Bowes
15 Sep 2022
21 CFR 80.37
Treatment of batch pending certification
Cited by Bhakti Petigara Harp, Kimberlee A Ewing, Bryan K Bowes
15 Sep 2022
21 CFR 80.37
Treatment of batch pending certification
Cited by Bhakti Petigara Harp, Kimberlee A Ewing, Bryan K Bowes
Investigators
FDA investigators tied to this site in the record.
State Agency4 insp.
Bhakti Petigara Harp3 insp.
Michael J Jackson2 insp.
Steven W Brown1 insp.
Kimberlee A Ewing1 insp.
Bryan K Bowes1 insp.
Eric C Nielsen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 80.37 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 80.38(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Roha USA, LLC's 6 Form 483s
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