Walter C. Nimocks
General Manager
Sohgave LLC
4500 N Sam Houston Pkwy W Ste 120
Houston , TX 77086-1473
United StatesFEI 3015106322Issued Jan 19, 2023Division of Southwest Imports
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 3015106322.
Violations1
Issue DateJan 19, 2023
Product TypeOther
StatusClosed
Closeout LetterDec 31, 2024
Letter Details
Firm
Sohgave LLC
Location
Walter C. Nimocks
General Manager
Sohgave LLC
4500 N Sam Houston Pkwy W Ste 120
Houston , TX 77086-1473
United States
FEI Number
3015106322
Country
United States
Issue Date
January 19, 2023
Issuing Office
Division of Southwest Imports
Product Type
Other
Status
Closed
Closeout Letter
December 31, 2024
Summary
Sohgave LLC, a food and beverage importer based in Houston, Texas, failed to comply with Foreign Supplier Verification Program (FSVP) requirements under section 805 of the Federal Food, Drug, and Cosmetic Act during FDA inspections conducted in August 2021 and October 2022. The company did not perform the required risk-based verification activities to ensure imported foods met applicable U.S. food safety standards as mandated by 21 CFR part 1, subpart L. Although Sohgave committed to completing FSVP documentation by November 30, 2022, the company failed to provide supporting documentation of corrective actions when requested by FDA's compliance officer on November 16, 2022, leaving the agency unable to evaluate the adequacy of their response.