Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2013-05-07.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Apr 2013 – 7 May 2013 | Human Drugs | 483 | View 483 → |
| 28 Feb 2011 | Not recorded | 483 | View 483 → |
| 25 Jun 2009 | Not recorded | 483 | View 483 → |
| 22 May 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
7 May 2013
21 CFR 211.84(d)(2)
Component written specification
Cited by Marie B Buen-Bigornia, Kimberley A Hoefen
7 May 2013
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Marie B Buen-Bigornia, Kimberley A Hoefen
7 May 2013
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Marie B Buen-Bigornia, Kimberley A Hoefen
7 May 2013
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Marie B Buen-Bigornia, Kimberley A Hoefen
7 May 2013
21 CFR 211.166(c)(1)
Homeopathic drugs, assessment of stability
Cited by Marie B Buen-Bigornia, Kimberley A Hoefen
Investigators
FDA investigators tied to this site in the record.
Marie B Buen-Bigornia1 insp.
Kimberley A Hoefen1 insp.
Theressa B Smith1 insp.
Hanna L Potter1 insp.
Toni L Morales1 insp.
Anthony J Lagreca1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(c)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind New Vistas Incorporated's 3 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