ISE America Inc.
Form 483 issued October 15, 2010 · Newberry, South Carolina
- Inspection
- Oct 15, 2010
- Observations
- 7
- Pages
- 2
- FEI number
- 3002954898
In short: On October 15, 2010, FDA issued a Form 483 with 7 observations to ISE America Inc. in Newberry, South Carolina (FEI 3002954898) after an inspection that ran Oct 15, 2010. 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 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Records documenting compliance with rodents and other pest control measures show documentation inconsistencies among layer houses…
- 02
Complex and contractor logs are in need of update with currently approved…
- 03
The time of activity that the record…
- 04
Refrigeration temperatures of the egg storage cooler in use at the house was in excess of…
This inspection in context
Questions about this 483
What did FDA find at ISE America Inc.?
FDA listed 7 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.
When was ISE America Inc. inspected by FDA?
The inspection ran Oct 15, 2010, and the Form 483 is dated October 15, 2010.
How do I get the full Form 483 for ISE America 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.