# FDA 483 - Big Olaf Creamery LLC dba Big Olaf - September 01, 2022

Source: https://www.keypedia.com/records/483/big-olaf-creamery-llc-dba-big-olaf/6bfd1c24-8d1a-479a-bef8-175cff62f133

> FDA 483 for Big Olaf Creamery LLC dba Big Olaf on September 01, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Big Olaf Creamery LLC dba Big Olaf
- Inspection Date: 2022-09-01
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Big Olaf Creamery LLC dba Big Olaf in Sarasota, FL, revealed significant deficiencies in their food safety program, particularly after their RTE ice cream products were implicated in a Listeria monocytogenes outbreak. The firm lacked a written food safety plan, hazard analysis, environmental pathogen controls, and allergen management procedures. Additionally, the inspection noted inadequate employee training and hygiene practices, contributing to a high risk of product contamination.

## Related Documents

- [WARNING_LETTER - 2022-09-01](https://www.keypedia.com/records/warning_letter/big-olaf-creamery-llc-dba-big-olaf/b7268bda-1f17-4b31-b4ce-7d711401e9ca)

## Related Officers

- [Carol S. Davis](https://www.keypedia.com/people/carol-s-davis/7598c8b0-7fe2-424c-8bfd-ffa52ce715e3)
- [David P. King](https://www.keypedia.com/people/david-p-king/b420ffcd-5ae1-40d3-a72a-5ac41bdba0eb)
- [Megan K. Otero](https://www.keypedia.com/people/megan-k-otero/bac65e8e-6e3f-4547-8627-5fb299853eb6)
- [Tracy L. Reed](https://www.keypedia.com/people/tracy-l-reed/cf1e7d19-b0d5-4462-908c-07d2971a0973)

Company: https://www.keypedia.com/companies/big-olaf-creamery-llc-dba-big-olaf/fa6123a9-9f0d-4778-a284-2bdfc9fcfbd6

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6