Hillandale Farms of Iowa, Inc.
Form 483 issued August 26, 2010 · New Hampton, Iowa
- Inspection
- Aug 19 – Aug 26, 2010
- Investigators
- Connie Y. Fisher· James R. Hane· Jeffrey B. Moody
- Observations
- 6
- Pages
- 4
- FEI number
- 3004354976
In short: On August 26, 2010, FDA issued a Form 483 with 6 observations to Hillandale Farms of Iowa, Inc. in New Hampton, Iowa (FEI 3004354976) after an inspection that ran Aug 19 – Aug 26, 2010. The investigators were Connie Y. Fisher, James R. Hane, Jeffrey B. Moody and Richard F. Lambert. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 118.10 (recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan).
At a glance
Observations span 1 system, led by food cgmp / preventive controls.
Most cited: 21 CFR 118.10 (3×) · 118.4 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You did not maintain documentation that the 19 week old pullets in house 4 at the…
- 02
The 'Written SE prevention plan was not…
- 03
You failed to take step~ to ensure that there is no introduct.ion or transfer of SE…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Connie Y. Fisher
1 document · 2010
Cites 118.10 (recordkeeping requirements for the salmonella enteritidis (se) prevention plan) more than any other section. Most of their documents are for sites in Iowa.
The firmHillandale Farms of Iowa, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 118.10
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hillandale Farms of Iowa, Inc.?
FDA listed 6 observations on this Form 483, mostly about food CGMP / preventive controls. 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 Hillandale Farms of Iowa, Inc.?
Connie Y. Fisher, James R. Hane, Jeffrey B. Moody and Richard F. Lambert are named on this Form 483, for the inspection of Aug 19 – Aug 26, 2010. Each investigator has a profile showing what they cite most.
When was Hillandale Farms of Iowa, Inc. inspected by FDA?
The inspection ran Aug 19 – Aug 26, 2010, and the Form 483 is dated August 26, 2010.
How do I get the full Form 483 for Hillandale Farms of Iowa, Inc.?
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.