Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2012-01-11.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Jan 2012 | Not recorded | WL | View 483 → |
| 26 Oct 2010 | Not recorded | 483 | View 483 → |
| 14 Dec 2009 | Not recorded | 483 | View 483 → |
| 13 Aug 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jan 2012
21 CFR 111.12
Personnel - quality control personnel - qualified
Cited by Maureen A Wentzel, Cynthia A Palmer
11 Jan 2012
21 CFR 111.70(b)(3)
Specifications - contamination limits
Cited by Maureen A Wentzel, Cynthia A Palmer
11 Jan 2012
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Maureen A Wentzel, Cynthia A Palmer
11 Jan 2012
21 CFR 111.75(c)(3)
Specifications met identity,purity, strength, comp; basis
Cited by Maureen A Wentzel, Cynthia A Palmer
Investigators
FDA investigators tied to this site in the record.
Maureen A Wentzel4 insp.
Cynthia A Palmer1 insp.
Maria A Reed1 insp.
Seth J Goldenberg1 insp.
Brandi L Garbutt1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.12 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.93 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.135 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.140(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.16 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.160(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.180(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.353 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.410(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.415(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind United Nutrition Labs Inc's 4 Form 483s
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