Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-24.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Jul 2024 – 24 Jul 2024 | Foods & Cosmetics | 483 | View 483 → |
| 29 Apr 2019 – 2 May 2019 | Foods & Cosmetics | Clean | |
| 16 Jun 2014 – 27 Jun 2014 | Foods & Cosmetics | Clean | |
| 17 Jun 2014 – 19 Jun 2014 | Foods & Cosmetics | 483 | On file |
| 30 Sep 2011 | Not recorded | 483 | On file |
| 25 Aug 2010 | Not recorded | Clean | |
| 18 Aug 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Jul 2024
21 CFR 117.135(c)(1)
Process preventive controls - Appropriate (Adequate)
Cited by Jane G Choi
24 Jul 2024
21 CFR 117.135(c)(1)
Process preventive controls - Appropriate (Adequate)
Cited by Jane G Choi
24 Jul 2024
21 CFR 117.80(c)
Manufacturing, processing, packing, holding - Controls
Cited by Jane G Choi
24 Jul 2024
21 CFR 117.80(c)
Manufacturing, processing, packing, holding - Controls
Cited by Jane G Choi
Investigators
FDA investigators tied to this site in the record.
Cindy W Lewis2 insp.
Cynthia L Mccommis2 insp.
Jane G Choi1 insp.
Thomas N Adjabeng1 insp.
Jeanne A Young1 insp.
Christopher Do1 insp.
Diyo R Rai1 insp.
Vi T Au1 insp.
Damon A Growl1 insp.
CNTRCTMNTR LEONGC1 insp.
Quynh Strandberg1 insp.
Jude C Dike1 insp.
Jennifer L Johnson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.135(c)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.20(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Premier Organics 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