Wolfgang P. Steitz
Owner/Manager
SCO Koladen LLC
751 N Canyons Pkwy
Livermore , CA 94551-9479
United StatesFEI 3007516001Issued Apr 14, 2022West Coast Import District Compliance Branch - Team 2 (WCID-CB)
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 3007516001.
Violations1
Issue DateApr 14, 2022
Product TypeOther
StatusOpen
Letter Details
Firm
SCO Koladen LLC
Location
Wolfgang P. Steitz
Owner/Manager
SCO Koladen LLC
751 N Canyons Pkwy
Livermore , CA 94551-9479
United States
FEI Number
3007516001
Country
United States
Issue Date
April 14, 2022
Issuing Office
West Coast Import District Compliance Branch - Team 2 (WCID-CB)
Product Type
Other
Status
Open
Summary
SCO Koladen LLC, a food and beverage importer based in California, failed to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) as required by federal law, despite prior inspection findings in 2019 and a December 2021 inspection. The company did not implement adequate risk-based verification activities to ensure that imported foods met U.S. food safety standards, as mandated under 21 CFR Part 1, Subpart L. Although the company committed to developing an FSVP by March 11, 2022, it failed to provide required FSVP records or documentation of corrections to the FDA.
SCO Koladen LLC FDA Warning Letter, April 14, 2022