Esbenshade Enterprise
Form 483 issued March 1, 2011 · Ronks, Pennsylvania
- Inspection
- Feb 25 – Mar 1, 2011
- Investigators
- Jason M. Sluzynski· Lauren N. Shade
- Observations
- 2
- Pages
- 1
- FEI number
- 3008778223
In short: On March 1, 2011, FDA issued a Form 483 with 2 observations to Esbenshade Enterprise in Ronks, Pennsylvania (FEI 3008778223) after an inspection that ran Feb 25 – Mar 1, 2011. The investigators were Jason M. Sluzynski and Lauren N. Shade. The most-cited regulation is 21 CFR 118.10 (recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan).
What FDA observed
Preview: the opening words of each observation- 01
Yoa do not have a…
- 02
You did not maintain records documenting compliance with rodent and…
This inspection in context
Jason M. Sluzynski
10 documents · 2010–2011
Cites 118.4 (salmonella enteritidis (se) prevention measures) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmEsbenshade Enterprise history
The site's inspection history, in date order.
Similar 483sOther sites cited under 118.10(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Esbenshade Enterprise?
FDA listed 2 observations on this Form 483. The most-cited regulation is 21 CFR 118.10 (recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan). The opening words of each observation are shown on this page.
Who inspected Esbenshade Enterprise?
Jason M. Sluzynski and Lauren N. Shade are named on this Form 483, for the inspection of Feb 25 – Mar 1, 2011. Each investigator has a profile showing what they cite most.
When was Esbenshade Enterprise inspected by FDA?
The inspection ran Feb 25 – Mar 1, 2011, and the Form 483 is dated March 1, 2011.
How do I get the full Form 483 for Esbenshade Enterprise?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.