Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-24.
At a glance
Inspections
8
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Mar 2026 – 24 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Dec 2023 – 14 Dec 2023 | Medical Devices & Rad Health | Clean | |
| 31 Oct 2017 – 3 Nov 2017 | Medical Devices & Rad Health | 483 | On file |
| 31 Jul 2013 – 6 Aug 2013 | Medical Devices & Rad Health | Clean | |
| 25 Mar 2011 | Not recorded | 483 | View 483 → |
| 14 Oct 2009 | Not recorded | 483 | View 483 → |
| 26 Mar 2009 | Not recorded | 483 | View 483 → |
| 8 Dec 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Mar 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Monica C Burgos Garcia, Lorraine N Williams
24 Mar 2026
ISO 13485:2016 Clause 7.5.1
Production and service provision not adequate
Cited by Monica C Burgos Garcia, Lorraine N Williams
24 Mar 2026
ISO 13485:2016 Clause 8.2.1
Information gathered in feedback process not used as input into risk management
Cited by Monica C Burgos Garcia, Lorraine N Williams
24 Mar 2026
ISO 13485:2016 Clause 8.3.1
Nonconforming product not identified and controlled
Cited by Monica C Burgos Garcia, Lorraine N Williams
24 Mar 2026
ISO 13485:2016 Clause 8.5.2
Corrective action not taken
Cited by Monica C Burgos Garcia, Lorraine N Williams
Investigators
FDA investigators tied to this site in the record.
Leo J Lagrotte2 insp.
Monica C Burgos Garcia1 insp.
Lorraine N Williams1 insp.
Suzanne M Healy1 insp.
Marvin A Marenco1 insp.
Matthew T Sanchez1 insp.
MDSAP harperd1 insp.
Melanie W Pishnery1 insp.
Nicole E Knowlton1 insp.
Joshua J Silvestri1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.3.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Linvatec Corp.'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