Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-23.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Aug 2024 – 23 Aug 2024 | Foods & Cosmetics | 483 | On file |
| 12 Oct 2020 – 20 Oct 2020 | Foods & Cosmetics | 483 | On file |
| 26 Nov 2013 – 3 Dec 2013 | Foods & Cosmetics | Clean | |
| 29 May 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
29 May 2012
21 CFR 118.4
Written SE plan lacks required elements
Cited by Jeanmaire Hryshko, Damon A Growl, Darla R Bracy
29 May 2012
21 CFR 118.4
Written SE plan not implemented/followed
Cited by Jeanmaire Hryshko, Damon A Growl, Darla R Bracy
29 May 2012
21 CFR 118.4(b)(2)
Cross contamination from equipment
Cited by Jeanmaire Hryshko, Damon A Growl, Darla R Bracy
29 May 2012
21 CFR 118.8(a)
Method to be used, environmental samples
Cited by Jeanmaire Hryshko, Damon A Growl, Darla R Bracy
29 May 2012
21 CFR 118.10(a)(3)(ii)
Rodent and pest control documentation
Cited by Jeanmaire Hryshko, Damon A Growl, Darla R Bracy
Investigators
FDA investigators tied to this site in the record.
State Agency2 insp.
Damon A Growl2 insp.
Maridali De Leon-Torres1 insp.
Jeanmaire Hryshko1 insp.
Darla R Bracy1 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 118.10(a)(3)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.4(b)(2) | 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 SKS Enterprise, Inc.'s 3 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