Big Olaf Creamery LLC dba Big Olaf

Warning LetterOpen

Mr. David S. Peachey Co-Owner and President Big Olaf Creamery LLC dba Big Olaf 2001 Cattlemen Rd Unit 123 Sarasota , FL 34232-6247 United States orders@bigolaf.comFEI 3004654033Issued Dec 9, 2022Division of Human and Animal Food Operations East IV

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3004654033.

Violations7

Issue DateDec 9, 2022

Product TypeFood & Beverages

StatusOpen

Letter Details

Firm: Big Olaf Creamery LLC dba Big Olaf
Location: Mr. David S. Peachey Co-Owner and President Big Olaf Creamery LLC dba Big Olaf 2001 Cattlemen Rd Unit 123 Sarasota , FL 34232-6247 United States orders@bigolaf.com
FEI Number: 3004654033
Country: United States
Issue Date: December 09, 2022
Issuing Office: Division of Human and Animal Food Operations East IV
Product Type: Food & Beverages
Status: Open

Summary

Big Olaf Creamery LLC manufactured ready-to-eat ice cream products that were linked to a multistate outbreak of Listeria monocytogenes infections affecting 28 people across 11 states, leading to a full product recall in July 2022. An FDA inspection from July to September 2022 identified serious violations of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventative Controls regulations under 21 CFR Part 117, determining that the ice cream products were adulterated due to preparation, packing, and storage under insanitary conditions that allowed contamination. Whole Genome Sequencing analysis confirmed that ice cream from the Sarasota, Florida facility was the source of the outbreak, with environmental and finished product samples matching the clinical strain.

Big Olaf Creamery LLC dba Big Olaf FDA Warning Letter, December 9, 2022