Rutledge B. Leland III
Owner
Carolina Seafood Inc.
22 Oak Street
McClellanville , SC 29458
United States
Carolina.seafood@gmail.comFEI 1048071Issued Aug 21, 2025Human Foods Program
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 1048071.
Violations5
Issue DateAug 21, 2025
Product TypeFood & Beverages
StatusOpen
Letter Details
Firm
Carolina Seafood Inc.
Location
Rutledge B. Leland III
Owner
Carolina Seafood Inc.
22 Oak Street
McClellanville , SC 29458
United States
Carolina.seafood@gmail.com
FEI Number
1048071
Country
United States
Issue Date
August 21, 2025
Issuing Office
Human Foods Program
Product Type
Food & Beverages
Status
Open
Summary
Carolina Seafood Inc. was warned about serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations in their ready-to-eat crab dip and shrimp dip products during an inspection conducted April 29-May 2, 2025. The FDA found that the company failed to develop and implement compliant HACCP plans for these products, rendering them adulterated under federal law as they may have been prepared, packed, or held under conditions that could injure health. Despite the company's submission of revised HACCP plans in response to the initial FDA-483 observations, the FDA remained unsatisfied with the adequacy of the HACCP program documentation for the seafood products. The violations specifically involved deficiencies in hazard analysis documentation required under Title 21, Code of Federal Regulations, Part 123.
Carolina Seafood Inc. FDA Warning Letter, August 21, 2025