Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2013-07-03.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Jun 2013 – 3 Jul 2013 | Foods & Cosmetics | Clean | |
| 27 Aug 2012 | Not recorded | Clean | |
| 23 Apr 2012 | Not recorded | Clean | |
| 29 Mar 2012 | Not recorded | 483 | View 483 → |
| 15 Feb 2012 | Not recorded | 483 | On file |
| 12 Apr 2011 | Not recorded | 483 | View 483 → |
| 8 Jul 2009 | Not recorded | Clean | |
| 31 Jul 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Mar 2012
21 CFR 111.27(b)
Instruments - calibration
Cited by Dennis R Hock, Katelyn A Staub-Zamperini, Mary R Kirker
29 Mar 2012
21 CFR 111.35(b)(2)
Document-equipment date of use, maintain, clean, sanitize
Cited by Dennis R Hock, Katelyn A Staub-Zamperini, Mary R Kirker
29 Mar 2012
21 CFR 111.55
Production, process controls - packaged, labeled
Cited by Dennis R Hock, Katelyn A Staub-Zamperini, Mary R Kirker
29 Mar 2012
21 CFR 111.70(a)
Specifications - manufacturing process
Cited by Dennis R Hock, Katelyn A Staub-Zamperini, Mary R Kirker
29 Mar 2012
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Dennis R Hock, Katelyn A Staub-Zamperini, Mary R Kirker
Investigators
FDA investigators tied to this site in the record.
Erica L Nicoll6 insp.
Katelyn A Staub-Zamperini5 insp.
Dennis R Hock4 insp.
Mary R Kirker4 insp.
Tammy M Phillips1 insp.
Marjorie L Davis1 insp.
Daniel R Tammariello1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.260(l)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.27(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.35(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.415 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.55 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.303 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.460(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 1x |
| FDCA 761(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind MADE Inc.'s 3 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