Overview
- 10 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-06-07.
At a glance
Inspections
10
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Jun 2017 – 7 Jun 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Oct 2016 – 12 Oct 2016 | Medical Devices & Rad Health | WL | View 483 → |
| 4 Jun 2013 – 7 Jun 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Jun 2011 | Not recorded | 483 | View 483 → |
| 28 Jul 2010 | Not recorded | Clean | |
| 19 Aug 2008 | Not recorded | 483 | On file |
| 18 Nov 2005 | Not recorded | Clean | |
| 30 Sep 2004 | Not recorded | Clean | |
| 30 Sep 2003 | Not recorded | Clean | |
| 16 Oct 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Jun 2017
21 CFR 820.70(e)
Contamination control, Lack of or inadequate procedures
Cited by Cynthia L Gorveatt
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind United Contact Lens, Inc.'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