Overview
- 7 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-03.
At a glance
Inspections
7
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jan 2025 – 3 Feb 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Aug 2022 – 4 Aug 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 Nov 2019 – 15 Nov 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Feb 2017 – 15 Feb 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Jun 2014 – 24 Jun 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Dec 2011 | Not recorded | 483 | View 483 → |
| 15 Apr 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Feb 2025
21 CFR 803.17(a)(3)
Lack of System for Timely Submission of Reports
Cited by Frank J Marciniak
3 Feb 2025
21 CFR 803.17(a)(3)
Lack of System for Timely Submission of Reports
Cited by Frank J Marciniak
Investigators
FDA investigators tied to this site in the record.
Frank J Marciniak1 insp.
Kwong P Lee1 insp.
Gobiga Vanniyasingam1 insp.
Michelle L Johnson1 insp.
Loretta Nemchik1 insp.
Lauren L Vajo1 insp.
Amy M Cramer1 insp.
Kinh Q Mac1 insp.
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 | 13x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.17(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184(d) | 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(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lingraphicare America, Inc.'s 7 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