Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-02.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Mar 2026 – 2 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Nov 2022 – 21 Nov 2022 | Medical Devices & Rad Health | Clean | |
| 25 Feb 2019 – 27 Feb 2019 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Apr 2026
ISO 13485:2016 Clause 7.5.8
No documented system to assign unique device identification (UDI)
Cited by Jenny L Chisem
27 Feb 2019
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Christine I Shaw, Marcia G Evans
27 Feb 2019
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Christine I Shaw, Marcia G Evans
27 Feb 2019
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Christine I Shaw, Marcia G Evans
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 3x |
| ISO 13485:2016 Clause 7.5.8 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.3 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind NEW LIFE DIAGNOSTICS, 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