Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-07-02.
At a glance
Inspections
8
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Jun 2026 – 2 Jul 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Jan 2020 – 8 Jan 2020 | Medical Devices & Rad Health | Clean | |
| 5 Jun 2017 – 9 Jun 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Apr 2013 – 10 Apr 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Jan 2011 | Not recorded | Clean | |
| 22 Dec 2009 | Not recorded | WL | View 483 → |
| 7 Sep 2006 | Not recorded | Clean | |
| 29 Jul 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Jul 2026
ISO 13485:2016 Clause 6.2(e)
Records of personnel competence not maintained
Cited by Dawn M Braswell
2 Jul 2026
ISO 13485:2016 Clause 8.2.4
Internal audits not conducted to ensure QMS meets requirements and is effective
Cited by Dawn M Braswell
2 Jul 2026
ISO 13485:2016 Clause 8.5.1
Changes to maintain QMS and device not identified and implemented
Cited by Dawn M Braswell
Investigators
FDA investigators tied to this site in the record.
Dawn M Braswell2 insp.
Myoshi M Francis2 insp.
Miaja Umaedi1 insp.
Perry H Gambrell1 insp.
Trang N Cox1 insp.
Ana L Kewes1 insp.
Xiomara Copeland1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.2(e) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Encompass Group LLC's 4 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