Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-23.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Aug 2024 – 23 Aug 2024 | Biologics | 483 | View 483 → |
| 5 Apr 2019 | Biologics | Clean | |
| 16 May 2016 | Biologics | Clean | |
| 14 Dec 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Aug 2024
21 CFR 1271.200(c)
Calibration procedures and schedules (general)
Cited by Richard J Bashay
Investigators
FDA investigators tied to this site in the record.
Richard J Bashay1 insp.
Amanda B Athey1 insp.
Amanda B Vega1 insp.
Brandon L Mariner1 insp.
Kelly Dragon1 insp.
Patricia A Morrow1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.200(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.260(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Supreme Orthopedic Systems Inc's 2 Form 483s
Source PDFs 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