Berkshire Layers
Form 483 issued April 6, 2011 · Hamburg, Pennsylvania
- Inspection
- Apr 5 – Apr 6, 2011
- Investigators
- Brian S. Keefer· James M. Mason· Joshua C. Schafer
- Observations
- 3
- Pages
- 1
- FEI number
- 3008777805
In short: On April 6, 2011, FDA issued a Form 483 with 3 observations to Berkshire Layers in Hamburg, Pennsylvania (FEI 3008777805) after an inspection that ran Apr 5 – Apr 6, 2011. The investigators were Brian S. Keefer, James M. Mason and Joshua C. Schafer. 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 do not maintain records documenting…
- 02
All your required records do not include the time of the activity…
- 03
All required records do not have the signature or initials of the person performing the operation…
This inspection in context
Brian S. Keefer
6 documents · 2011–2019
Cites 118.10(a)(3)(iv) (recordkeeping requirements for the salmonella enteritidis (se) prevention plan) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmBerkshire Layers history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 118.10(a)(3)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Berkshire Layers?
FDA listed 3 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 Berkshire Layers?
Brian S. Keefer, James M. Mason and Joshua C. Schafer are named on this Form 483, for the inspection of Apr 5 – Apr 6, 2011. Each investigator has a profile showing what they cite most.
When was Berkshire Layers inspected by FDA?
The inspection ran Apr 5 – Apr 6, 2011, and the Form 483 is dated April 6, 2011.
How do I get the full Form 483 for Berkshire Layers?
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.