Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-31.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Jan 2024 – 31 Jan 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Feb 2015 – 19 Mar 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Jul 2012 | Not recorded | 483 | View 483 → |
| 18 Aug 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Jan 2024
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Monica C Burgos Garcia
31 Jan 2024
21 CFR 820.30(h)
Design transfer - Lack of or inadequate procedures
Cited by Monica C Burgos Garcia
31 Jan 2024
21 CFR 820.50(a)(3)
Acceptable supplier records, inadequate records
Cited by Monica C Burgos Garcia
19 Mar 2015
21 CFR 806.10(a)(1)
Report of risk to health
Cited by Dianiris C Ayala, Leslie A Jackanicz, Leslie A Cartmill
Investigators
FDA investigators tied to this site in the record.
Joshua J Silvestri2 insp.
Monica C Burgos Garcia1 insp.
Dianiris C Ayala1 insp.
Leslie A Jackanicz1 insp.
Leslie A Cartmill1 insp.
Melanie G Warzala1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.120 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Spinalight, Inc.'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