Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-05.
At a glance
Inspections
7
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Feb 2026 – 5 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Sep 2023 – 11 Sep 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Oct 2019 – 21 Oct 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Mar 2016 – 14 Mar 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Aug 2012 | Not recorded | Clean | |
| 4 Jan 2012 | Not recorded | WL | |
| 7 May 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Feb 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Jaro P Perera
5 Feb 2026
ISO 13485:2016 Clause 7.4.3
Purchased product verification activities are inadequate
Cited by Jaro P Perera
11 Sep 2023
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Matthew W Kyle, Naakesh N Gomanie, Jonathan Ho
11 Sep 2023
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Matthew W Kyle, Naakesh N Gomanie, Jonathan Ho
21 Oct 2019
21 CFR 820.198(c)
Investigation of device failures
Cited by William R Chang, Diane B Radice
Investigators
FDA investigators tied to this site in the record.
Eric J Cunningham3 insp.
Jaro P Perera1 insp.
Matthew W Kyle1 insp.
Naakesh N Gomanie1 insp.
Jonathan Ho1 insp.
William R Chang1 insp.
Diane B Radice1 insp.
Melissa A Freeman1 insp.
Frank J Marciniak1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.3 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Life Recovery Systems HD, LLC's 5 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