Overview
- 5 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
SESKS Enterprise, Inc.Lodi, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| 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 483 report
Get the verbatim text of all 5 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere