# FDA 483 - Artisan Kitchens LLC - October 15, 2010

Source: https://www.globalkeysolutions.net/records/483/artisan-kitchens-llc/4ecff5f8-6243-4c2c-965d-ec1ae97bd454

> FDA 483 for Artisan Kitchens LLC on October 15, 2010. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Artisan Kitchens LLC
- Inspection Date: 2010-10-15
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA inspection of ISE America, Inc., an egg producer/processor located at 2063 Alexander Street, Newberry, SC 29108, was conducted from September 28, 2010, to October 15, 2010. The inspection revealed several observations regarding compliance with SE Prevention Plans and facility maintenance.

Observations included:
1.  **Pest Control Inconsistencies:** Records for rodent and pest control showed inconsistencies among layer houses. Daily rodent activity documentation varied, with some contractors documenting sightings, others noting daily checks, and some not documenting at all. Pesticide Usage Forms were not consistently utilized across all contractor poultry houses, and information within them, such as usage quantities, was often incomplete.
2.  **Outdated Documentation:** Complex and contractor links needed updates with currently approved forms and required information, as Pesticide Usage Forms/Pest Control Logs and Fly Monitoring documents differed among contractors.
3.  **Lack of Time Documentation:** Records such as Layer Service Reports, Rodent Sightings Logs, and Fly Control documents did not include the time of activity.
4.  **Refrigeration Temperature Exceedance:** The egg storage cooler in one house consistently exceeded 45°F, the specified temperature in the SE Prevention Plan, from September 17, 2010, to October 1, 2010. Eggs were reportedly picked up weekly from

Company: https://www.globalkeysolutions.net/companies/artisan-kitchens-llc/fe1dcb49-5883-4746-b1b0-85f5350af05e

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c