Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-23.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 May 2024 – 23 May 2024 | Medical Devices & Rad Health | Clean | |
| 22 Sep 2020 – 29 Sep 2020 | Medical Devices & Rad Health | Clean | |
| 9 Apr 2019 – 16 Apr 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Jan 2018 – 12 Feb 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Feb 2015 – 4 Feb 2015 | Medical Devices & Rad Health | Clean | |
| 23 Apr 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Apr 2019
21 CFR 820.75(b)(2)
Documentation of validated process performance
Cited by Juanita Banuelos
16 Apr 2019
21 CFR 820.75(b)(2)
Documentation of validated process performance
Cited by Juanita Banuelos
12 Feb 2018
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Kirtida Patel
Investigators
FDA investigators tied to this site in the record.
Juanita Banuelos2 insp.
State Agency1 insp.
Kirtida Patel1 insp.
Kimberly M Lichter1 insp.
Mei-Chen Mu1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(b)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind ARMM Inc's 2 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