Overview
- 6 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-05-27.
At a glance
Inspections
6
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 May 2016 – 27 May 2016 | Foods & Cosmetics | 483 | View 483 → |
| 13 Aug 2015 – 28 Aug 2015 | Foods & Cosmetics | 483 | View 483 → |
| 3 Sep 2014 – 25 Sep 2014 | Human Drugs | 483 | On file |
| 6 Nov 2012 | Not recorded | 483 | View 483 → |
| 3 Oct 2011 | Not recorded | 483 | View 483 → |
| 9 Jun 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
27 May 2016
21 CFR 111.560(a)(2)
Product complaint - quality control investigate
Cited by Quynh Strandberg, Edna J Hidalgo
27 May 2016
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Quynh Strandberg, Edna J Hidalgo
27 May 2016
21 CFR 111.210(h)(2)
Master manufacturing record - sampling, tests, examinations
Cited by Quynh Strandberg, Edna J Hidalgo
27 May 2016
21 CFR 111.70(b)(1)
Specifications - component identity
Cited by Quynh Strandberg, Edna J Hidalgo
Investigators
FDA investigators tied to this site in the record.
Quynh Strandberg2 insp.
Edna J Hidalgo2 insp.
Mark A Chen2 insp.
Karen D Phung1 insp.
Maida Henesian1 insp.
Wen-Jun Peng1 insp.
Ronald P Boyce1 insp.
Michael C Nausin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(h)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(c)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.117(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j)(2)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.530 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.73 | 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 111.83(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Custompax, Inc., dba Vitaganic's 6 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