Arlin D. Wadel
Form 483 issued February 11, 2011 · Shippensburg, Pennsylvania
- Inspection
- Feb 11, 2011
- Investigators
- John M. Mastalski· Margaret E. Digennaro
- Observations
- 5
- Pages
- 2
- FEI number
- 3008780083
In short: On February 11, 2011, FDA issued a Form 483 with 5 observations to Arlin D. Wadel in Shippensburg, Pennsylvania (FEI 3008780083) after an inspection that ran Feb 11, 2011. The investigators were John M. Mastalski and Margaret E. Digennaro. 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
You did not maintain records documenting compliance with rodent and…
- 02
All required records do not have the signature or initials of the person performing the operation…
- 03
All your required records do not include the time ofthe activity…
- 04
All required records do not include your name and the…
This inspection in context
John M. Mastalski
15 documents · 2010–2019
Cites 118.10(a)(3)(ii) (recordkeeping requirements for the salmonella enteritidis (se) prevention plan) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmArlin D. Wadel history
The site's inspection history, in date order.
Similar 483sOther sites cited under 118.10(b)(3)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Arlin D. Wadel?
FDA listed 5 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 Arlin D. Wadel?
John M. Mastalski and Margaret E. Digennaro are named on this Form 483, for the inspection of Feb 11, 2011. Each investigator has a profile showing what they cite most.
When was Arlin D. Wadel inspected by FDA?
The inspection ran Feb 11, 2011, and the Form 483 is dated February 11, 2011.
How do I get the full Form 483 for Arlin D. Wadel?
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.