Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2012-06-27.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Jun 2012 | Not recorded | Clean | |
| 22 Jul 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Jul 2011
21 CFR 118.4
Written SE plan lacks required elements
Cited by Weston K Szymanski, Andrew A Hoopes
22 Jul 2011
21 CFR 118.4
Written SE plan not implemented/followed
Cited by Weston K Szymanski, Andrew A Hoopes
22 Jul 2011
21 CFR 118.4(c)(1)
Satisfactory rodent control methods
Cited by Weston K Szymanski, Andrew A Hoopes
Investigators
FDA investigators tied to this site in the record.
Lori Gioia1 insp.
Kellia N Hicks1 insp.
Brittany D Terhar1 insp.
Jessica E Hensley1 insp.
Julie N Vosilus1 insp.
Adree N Anderson1 insp.
Weston K Szymanski1 insp.
Andrew A Hoopes1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 118.4 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 118.4(c)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 118.10(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.4(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.4(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.8(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind New Horizon Cooperative's 1 Form 483
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