Denny Wagner
Form 483 issued June 30, 2011 · Muncy, Pennsylvania
- Inspection
- Jun 30, 2011
- Investigators
- Brandon J. Brookens· Michael J. Mero
- Observations
- 6
- Pages
- 2
- FEI number
- 3008778607
In short: On June 30, 2011, FDA issued a Form 483 with 6 observations to Denny Wagner in Muncy, Pennsylvania (FEI 3008778607) after an inspection that ran Jun 30, 2011. The investigators were Brandon J. Brookens and Michael J. Mero. 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
Observation 1: scanned text, readable in the full document.
- 02
Your firm does not have a written SE prevention plan that is specific to the farm…
- 03
You did not maintain records documenting compliance with rodent and other…
- 04
All your required records do not include the time ofthe activity that…
This inspection in context
Brandon J. Brookens
16 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 firmDenny Wagner history
The site's inspection history, in date order.
Similar 483sOther sites cited under 118.4(b)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Denny Wagner?
FDA listed 6 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 Denny Wagner?
Brandon J. Brookens and Michael J. Mero are named on this Form 483, for the inspection of Jun 30, 2011. Each investigator has a profile showing what they cite most.
When was Denny Wagner inspected by FDA?
The inspection ran Jun 30, 2011, and the Form 483 is dated June 30, 2011.
How do I get the full Form 483 for Denny Wagner?
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.