Overview
- 9 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-12-13.
At a glance
Inspections
9
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Dec 2024 – 13 Dec 2024 | Foods & Cosmetics | 483 | View 483 → |
| 8 Apr 2022 – 13 Apr 2022 | Foods & Cosmetics | 483 | View 483 → |
| 10 Jul 2018 – 17 Jul 2018 | Foods & Cosmetics | Clean | |
| 27 Jul 2015 – 31 Jul 2015 | Foods & Cosmetics | 483 | View 483 → |
| 17 Jun 2013 – 20 Jun 2013 | Foods & Cosmetics | 483 | View 483 → |
| 19 Dec 2011 | Not recorded | 483 | View 483 → |
| 12 Apr 2010 | Not recorded | 483 | On file |
| 5 Aug 2008 | Not recorded | Clean | |
| 19 Feb 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Dec 2024
21 CFR 111.210
Master manufacturing record - record requirements
Cited by Jean C Colon Lopez
Investigators
FDA investigators tied to this site in the record.
Cntrctmntr Savini2 insp.
Jean C Colon Lopez1 insp.
Celia L Hutchinstein1 insp.
Michael S Hudson1 insp.
Keegan B Mixon1 insp.
Jeffrey J Leclair1 insp.
Elizabeth S Howell1 insp.
Maria P Kelly-Doggett1 insp.
Thomas C Mclean1 insp.
Ian J Thomson1 insp.
Crystal A Harlan1 insp.
State Agency1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.255(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.10(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.10(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(d)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.360 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.77(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Eclectic Institute Inc's 6 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