Overview
- 12 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-27.
At a glance
Inspections
12
Form 483s
7
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Feb 2025 | Foods & Cosmetics | Clean | |
| 15 Nov 2022 – 22 Nov 2022 | Foods & Cosmetics | Clean | |
| 8 Jul 2020 | Foods & Cosmetics | Clean | |
| 5 Jul 2017 – 11 Jul 2017 | Foods & Cosmetics | 483 | View 483 → |
| 8 Mar 2016 – 10 Mar 2016 | Foods & Cosmetics | Clean | |
| 19 Feb 2013 – 13 Mar 2013 | Foods & Cosmetics | 483 | View 483 → |
| 3 Jul 2012 | Not recorded | WL | View 483 → |
| 4 May 2011 | Not recorded | 483 | View 483 → |
| 12 Apr 2011 | Not recorded | 483 | On file |
| 2 Dec 2009 | Not recorded | 483 | View 483 → |
| 4 Mar 2009 | Not recorded | Clean | |
| 18 Feb 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jul 2017
21 CFR 123.9(a)
Records - content
Cited by Jennifer M Heitz, Brittany M Kershaw, Amy L Mccarthy
11 Jul 2017
21 CFR 123.9(a)
Records - content
Cited by Jennifer M Heitz, Brittany M Kershaw, Amy L Mccarthy
11 Jul 2017
21 CFR 123.9(a)
Records - content
Cited by Jennifer M Heitz, Brittany M Kershaw, Amy L Mccarthy
Investigators
FDA investigators tied to this site in the record.
State Agency5 insp.
Diane M Fresch4 insp.
Kathryn J Mccarty2 insp.
Benjamin P Stewart1 insp.
Jennifer M Heitz1 insp.
Brittany M Kershaw1 insp.
Amy L Mccarthy1 insp.
Susan M Taylor1 insp.
Annemarie H Cochran1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 123.9(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 123.6(c)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 110.37(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sea One Enterprises, Inc.'s 7 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