Sol-ti Inc.

Warning LetterOpen

Mr. Ryne O’Donnell CEO Sol-ti Inc. 8380 Miralani Dr, Ste A San Diego , CA 92126 United StatesFEI 3013414473Issued Mar 16, 2023Division of Human and Animal Food Operations West V

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Letter Details

Firm: Sol-ti Inc.
Location: Mr. Ryne O’Donnell CEO Sol-ti Inc. 8380 Miralani Dr, Ste A San Diego , CA 92126 United States
FEI Number: 3013414473
Country: United States
Issue Date: March 16, 2023
Issuing Office: Division of Human and Animal Food Operations West V
Product Type: Food & Beverages
Status: Open

Summary

Sol-ti Inc. was cited for serious violations of juice HACCP regulations at its San Diego facility, with its ready-to-drink juice products and juice ingredients deemed adulterated due to preparation under insanitary conditions. The company's HACCP plan for SuperShot and SuperAde products failed to include validated control measures demonstrating a 5-log reduction of resistant microorganisms like Cryptosporidium parvum and E. coli O157:H7, and the UV Treatment critical control point lacked proper validation to achieve the required microbial reduction for the product shelf life. The FDA issued this warning letter on March 16, 2023, following an inspection conducted from December 19, 2022, through February 8, 2023, and after reviewing the company's February 28, 2023 response to the inspection findings.