Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-28.
At a glance
Inspections
4
Form 483s
2
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Aug 2025 – 28 Aug 2025 | Human Drugs | Clean | |
| 8 Jul 2019 – 11 Jul 2019 | Human Drugs | 483 | View 483 → |
| 22 Jan 2019 – 29 Jan 2019 | Human Drugs | Clean | |
| 1 Dec 2015 – 14 Dec 2015 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jul 2019
21 CFR 211.192
Written record of investigation incomplete
Cited by Jennifer L Huntington, Jason D Abel
11 Jul 2019
21 CFR 211.192
Written record of investigation incomplete
Cited by Jennifer L Huntington, Jason D Abel
14 Dec 2015
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Paul A Licata, Joanne E King
14 Dec 2015
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Paul A Licata, Joanne E King
14 Dec 2015
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Paul A Licata, Joanne E King
Investigators
FDA investigators tied to this site in the record.
Alan A Rivera1 insp.
Jennifer L Huntington1 insp.
Jason D Abel1 insp.
Saundrea A Munroe1 insp.
Paul A Licata1 insp.
Joanne E King1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind SHL Medical Assembly & Services LLC'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