Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-01-25.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Jan 2021 – 25 Jan 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Jun 2017 – 14 Jun 2017 | Medical Devices & Rad Health | Clean | |
| 16 Sep 2013 – 28 Oct 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Feb 2010 | Not recorded | 483 | View 483 → |
| 18 Nov 2004 | Not recorded | Clean | |
| 28 Feb 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jan 2021
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Christine I Shaw
25 Jan 2021
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Christine I Shaw
Investigators
FDA investigators tied to this site in the record.
Christine I Shaw1 insp.
Daniel J Lahar1 insp.
Felix J Marrero1 insp.
Marc A Jackson1 insp.
Kimetha A King1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.170(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | 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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind nSpire Health, Inc.'s 3 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