Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-07-10.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Jul 2017 | Medical Devices & Rad Health | Clean | |
| 13 Apr 2011 | Not recorded | 483 | View 483 → |
| 29 Jan 2009 | Not recorded | 483 | View 483 → |
| 7 Nov 2006 | Not recorded | Clean | |
| 11 Feb 2005 | Not recorded | Clean | |
| 12 Nov 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Apr 2011
21 CFR 806.10(a)(2)
Report of violation of the Act (see 803.52(e)(9))
Cited by Kirtida Patel, Durell L Giles
13 Apr 2011
21 CFR 820.30(g)
Design validation - user needs and intended uses
Cited by Kirtida Patel, Durell L Giles
Investigators
FDA investigators tied to this site in the record.
Leonard H Lavi1 insp.
Kirtida Patel1 insp.
Durell L Giles1 insp.
Herminio C Francisco1 insp.
Richard W Tubb1 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 | 3x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(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 820.184(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Newport Medical Instruments Inc's 2 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