Overview
- 11 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2021-07-22.
At a glance
Inspections
11
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jul 2021 – 22 Jul 2021 | Foods & Cosmetics | Clean | |
| 18 Jul 2018 | Foods & Cosmetics | Clean | |
| 4 Apr 2018 | Foods & Cosmetics | Clean | |
| 11 Jul 2016 – 21 Jul 2016 | Foods & Cosmetics | Clean | |
| 12 Mar 2015 | Foods & Cosmetics | Clean | |
| 12 Feb 2013 | Foods & Cosmetics | Clean | |
| 2 Feb 2012 | Not recorded | Clean | |
| 21 Jun 2011 | Not recorded | Clean | |
| 15 Jul 2010 | Not recorded | 483 | View 483 → |
| 24 Jun 2009 | Not recorded | Clean | |
| 16 Sep 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jul 2010
21 CFR 110.20(b)(4)
Drip and condensate
Cited by Sangeeta M Khurana, Jinkee M Vila Binayug, David L Hunsaker
15 Jul 2010
21 CFR 110.35(a)
Buildings/sanitary
Cited by Sangeeta M Khurana, Jinkee M Vila Binayug, David L Hunsaker
15 Jul 2010
21 CFR 110.40(a)
Precluding contaminants
Cited by Sangeeta M Khurana, Jinkee M Vila Binayug, David L Hunsaker
15 Jul 2010
21 CFR 110.80(b)(2)
Manufacturing conditions
Cited by Sangeeta M Khurana, Jinkee M Vila Binayug, David L Hunsaker
Investigators
FDA investigators tied to this site in the record.
State Agency6 insp.
Sandra K Wangen1 insp.
Kimberly J Proctor Jones1 insp.
Andrew K Haack1 insp.
Kristina M Phelps1 insp.
Sangeeta M Khurana1 insp.
Jinkee M Vila Binayug1 insp.
David L Hunsaker1 insp.
Jason T Lovelady1 insp.
Elizabeth S Howell1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Harry and David Operations Inc's 1 Form 483
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