Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2011-05-13.
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 |
|---|---|---|---|
| 13 May 2011 | Not recorded | 483 | View 483 → |
| 19 Nov 2009 | Not recorded | 483 | View 483 → |
| 14 Nov 2008 | Not recorded | 483 | View 483 → |
| 21 Feb 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
13 May 2011
21 CFR 110.20(b)(6)
Fans/air blowing equipment
Cited by Lisa A Warner, Neimar Lopez-Martinez
Investigators
FDA investigators tied to this site in the record.
Lisa A Warner1 insp.
Neimar Lopez-Martinez1 insp.
Sharon Giamberini1 insp.
Mary F Bodick1 insp.
Linda K Matheny1 insp.
Lundy H Patrick1 insp.
State Agency1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.37(d)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(5) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Gold'nkrackle, 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